Apparatus for treating gerd comprising a stimulation device

ABSTRACT

The present invention relates to a reflux disease treatment apparatus, apparatus, comprising an implantable movement restriction device that maintains cardia in the correct position and an implantable stimulation device adapted to engage with the cardia sphincter of a patient. The invention further comprises a control device for controlling the stimulation device to stimulate the cardia sphincter. The invention can be combined with various methods for treating obesity, in particular methods that creates satiety by stretching the wall of the stomach or fills out a volume of the stomach.

This application is a continuation of U.S. patent application Ser. No.12/864,852, filed 27 Jul. 2010, which is the U.S. national phase ofinternational Application No. PCT/SE2009/000057, filed 29 Jan. 2009,which designated the U.S. and claims priority to U.S. Application No.61/006,719, filed 29 Jan. 2008 and Swedish Application No. 0802138-8,filed 10 Oct. 2008, the entire contents of each of which are herebyincorporated by reference.

TECHNICAL FIELD

The present invention relates to an apparatus for treatingGastroesophageal Reflux Disease (GERD).

The present invention relates to a reflux disease treatment apparatus,comprising an implantable movement restriction device that maintains thecardia in the correct position and an implantable stimulation deviceadapted to engage with the cardia sphincter of a patient. The inventionfurther comprises a control device for controlling the stimulationdevice to stimulate the cardia sphincter. The invention can be combinedwith various methods for treating obesity, in particular methods thatcreates satiety by stretching the wall of the stomach or fills out avolume of the stomach.

BACKGROUND

Gastroesophageal Reflux Disease (GERD), or acid reflux disease, is achronic condition resulting in mucosal damage in the oesophagus producedby the recurring occurrence of acid reflux in the oesophagus. This iscommonly due to transient or permanent changes in the barrier betweenthe oesophagus and the stomach. This can be due to incompetence of thelower esophageal sphincter (LES), transient LES relaxation, impairedexpulsion of gastric reflux from the esophagus, or a hiatal hernia.

Gastroesophageal Reflux Disease can be treated in a number of differentways. Treatments include, but are not limited to, both medical andsurgical treatments. A standard surgical treatment, which sometimes ispreferred over longtime use of medication, is Nissen fundoplicationsurgery, in which the upper curve of the stomach (the fundus) is wrappedaround the LES to strengthen the sphincter and prevent acid reflux andto repair a hiatal hernia. The procedure is often done laparoscopically.

Another surgical treatment which has been used is the Anglechikprosthesis, in which a device formed like a horseshoe is placed aroundthe oesophagus above the cardia. The intended effect is to prevent thecardia from slipping up into the thorax cavity. However, this device hasa number of complications, including migrating through and damaging theoesophagus.

From experience with implantation of medical devices, it is known thatsutures between an implanted device and human tissue will not hold overthe long term. For long term implantation of a device, there are twopossibilities to keep the device in place. A first solution has been tosuture human tissue to human tissue, to thereby keep the device inplace. A second approach has been to provide sutures holding a device inplace in the short term and to allow in-growth of human tissue into thedevice for holding the device in place over the long term.

A problem with providing an implantable device associated with theoesophagus is that the outer surface of the oesophagus is only comprisedof oesophagus muscle tissue, which is very easy to damage or migratethrough. This is probably one reason why the Anglechik prosthesisdescribed above has resulted in many complications, such as migration.

The stomach, on the other hand, has a serosa on its outside, therebyproviding a much stronger membrane for suturing. Thus, suturing a devicedirectly to the stomach wall provides a better result than suturing animplanted device to the oesophagus.

Today, there exists a need for a long term treatment of GERD that ismore effective than prior treatments and which does not result in anysevere complications.

SUMMARY OF THE INVENTION

It is an object of the present invention to overcome, or at leastreduce, some of the problems associated with existing surgicaltreatments of Gastroesophageal Reflux Disease (GERD). It is anotherobject of the present invention to provide an apparatus for treatinggastroesophageal reflux disease. These objects and others are obtainedby the apparatus described in the appended claims. This object isobtained by providing an apparatus, the apparatus comprising animplantable movement restriction device adapted to be at least partlyinvaginated by the patient's stomach fundus wall and having an outersurface that includes a biocompatible material, wherein a substantialpart of the outer surface of the movement restriction device is adaptedto rest against the stomach wall without injuring the latter in aposition between the patient's diaphragm and at least a portion of thelower part of the invaginated stomach fundus wall, such that movement ofthe cardiac notch of the patient's stomach towards the patient'sdiaphragm is restricted, when the movement restriction device isinvaginated, to thereby prevent the cardia from sliding through thepatient's diaphragm opening into the patient's thorax, so as to maintainthe supporting pressure against the patient's cardia sphincter muscleexerted from the patient's abdomen, the movement restriction devicehaving a size of at least 125 mm³ and a circumference of at least 15 mm,further comprising an implantable stimulation device adapted to engagewith the cardia sphincter of a patient, and a control device forcontrolling the stimulation device to stimulate the cardia sphincter,wherein the stimulation of the cardia sphincter is made with energypulses to increase sphincter tonus so that the cardia closes and saidcontrol device is operable by the patient in that it can be set out ofoperation, wherein the control device is further operable by the patientto set the stimulation device into operation, in which operational statethe stimulation device continuously alternates at a time when thepatient does not swallow between an operation mode, in which the cardiasphincter is stimulated with said energy pulses, and a rest mode, inwhich the cardia sphincter is not stimulated.

Movement Restriction Device

Initially, the movement restriction device of the apparatus will bedescribed.

The apparatus comprises an implantable movement restriction devicehaving an outer surface that includes a biocompatible material, whereinthe movement restriction device is adapted to rest with at least a partof its outer surface against the patient's stomach fundus wall, in aposition between the patient's diaphragm and the fundus wall, such thatmovement of the cardiac notch of the patient's stomach towards thepatient's diaphragm is restricted, an apparatus for treatingGastroesophageal Reflux Disease is obtained. The movement restrictiondevice has a size of at least 125 mm³ and a circumference of at least 15mm and restricts movement of the cardiac notch of the patient's stomachtowards the patient's diaphragm thereby preventing the cardia fromsliding through the patient's diaphragm opening into the patient'sthorax, maintaining the supporting pressure against the patient's cardiasphincter muscle exerted from the patient's abdomen. Fixation device areadapted to secure the movement restriction device in said position.

By adapting the outer surface of the implanted movement restrictiondevice to rest against the wall of the fundus, there is a minimal riskof complications, such as migration of damage to tissue, because thefundus is less fragile than the oesophagus.

In a first embodiment of the invention, the fixation device comprisessutures or staples that attach together portions of the fundus stomachwall that enclose the movement restriction device to secure the movementrestriction device in said position. I.e., the movement restrictiondevice is at least partly placed in an invaginated space. Thus, byaffixing the implantable movement restriction device indirectly in thismanner, no suturing between the movement restriction device and tissueis required, which, in turn, further reduces the risk for complications.Keeping the movement restriction device in place in this manner hasresulted in an elastic suspension with improved long term properties.

The fixation device, such as sutures or staplers, may attach togetherportions of the fundus stomach wall so at to substantially or completelyinvaginate the movement restriction device from either inside or outsideof the patient's stomach wall. Where the movement restriction device isplaced on the outside of the patient's stomach wall, the movementrestriction device is invaginated by the fundus stomach wall such thatthe stomach cavity is substantially reduced, by a volume substantiallyexceeding the volume of the movement restriction device.

In a another embodiment of the invention, the fixation device comprisesan implantable first fixation device that attach the movementrestriction device in said position to the fundus wall, a secondfixation device that secures, indirectly or directly, the movementrestriction device to the oesophagus close to the patient's angle ofHis, and a third fixation device that secures, indirectly or directly,the movement restriction device to the patient's diaphragm muscle orassociated muscles. Any of the first, second and third fixation devicesmay be comprised of a plurality of sutures or staples. The firstfixation device may comprise a tissue growth promoting structure forlong term attachment of the movement restriction device to the stomachwall. The tissue growth promoting structure may be sutured to thestomach wall with a relatively large contact surface towards thestomach. The relatively large surface of the structure, such as a net,will allow for in-growth of human tissue for holding the movementrestriction device in place over the long term. The tissue growthpromoting structure may comprise sutures or staples that attach the netlike structure to the fundus stomach wall.

In addition to invaginating the movement restriction device inaccordance with the first embodiment of the invention, the secondfixation device can be used to secure, indirectly or directly, themovement restriction device to the oesophagus close to the patient'sangle of His, and the third fixation device may be used to secure,indirectly or directly, the movement restriction device to the patient'sdiaphragm muscle or associated muscles.

At least a part of the movement restriction device may be made of amaterial which is destructible or not destructible by stomach acid.

The movement restriction device may be inflatable and adapted to beinflated with a gel or fluid. A fluid or gel receiving member forreceiving fluid to inflate the movement restriction device may beprovided.

The movement restriction device may include a homogenous material andmay be a solid body.

The movement restriction device may include an enclosure wall defining achamber.

The movement restriction device may have a rigid, elastic or flexibleouter wall. Where the outer wall is rigid, it is rigid enough tomaintain non-deformed when subject to forces created by stomachmovements. Where the movement restriction device is invaginated, inaccordance with the first embodiment described above, the movementrestriction device preferably comprises a body adapted to be at leastpartly invaginated by the patient's stomach fundus wall and having anouter surface that includes a biocompatible material. A substantial partof the outer surface of the body is adapted to rest against the stomachwall in said position between the patient's diaphragm and the portion ofthe lower part of the invaginated stomach fundus wall. Suitably, thebody is made of a material softer than 25 or 15 shure.

In accordance with a first general design of the body, the body has amaximum circumference as seen in a plane perpendicular to an axisthrough the body. The circumferences of the body as seen in other planesperpendicular to said axis are equal to the maximum circumference ordecrease as seen along said axis in the direction from the maximumcircumference. For example, the body may be substantially egg shaped,spherically shaped, or substantially shaped like an egg with an indentedmiddle section or like a bent egg.

In accordance with a second general design of the body, thecircumference of the body as seen in a plane perpendicular to an axisthrough the body increases and decreases at least two times as the planeis displaced along said axis, or decreases and increases at least onetime as the plane is displaced along said axis. For example, the bodymay be substantially shaped like a kidney.

Preferably, the body is dimensioned with a size larger than theintestinal outlet from the stomach. The body may have a smallest outerdiameter of 30 or 40 mm or larger and may have a smallest outercircumference of 150, 110, 90, 70, 50 or 30 mm.

Suitably, the body has rounded contours without too sharp edges thatwould be damaging to the patient's stomach wall, and has a generallysmooth outer surface for resting against the fundus wall.

The body is implantable either inside or outside of the patient'sstomach and is adapted to be attached to the patient's stomach wall bysurgery. The body may be changeable to assume a slender form having asmaller diameter than that of a trocar for laparoscopic use, whereby thebody when changed to said slender form can be pushed or pulled throughthe trocar. The body may include a flexible outer wall defining achamber filled with a fluid, such as a gel, allowing the body to passthrough such a trocar. Alternatively, the body may include an elasticcompressible material, allowing the body to pass through a trocar.

The body may be hollow and include at least two separate pieces adaptedto be inserted into the hollow body, and further adapted to be puttogether to one unitary piece inside the body, thereby allowing the bodyto pass through a trocar for laparoscopic use. Alternatively, the bodymay include an outer wall and a hollow compressed inner part, for beingfilled with a fluid or gel after insertion into the patient's body.

The body may include a chamber with an injection port, wherein thechamber of the body is filled with a fluid through the injection port.

The body may include at least one holding device adapted to be used forpushing or pulling the body through a trocar for laparoscopic use. Theholding device is adapted to hold a prolongation of the body that isadapted to be held by a surgical instrument. More specifically, theholding device is adapted to hold a thread or band inserted through theholding device. Where the body comprises an outer wall the holdingdevice is at least partly placed inside the outer wall of the body.

In an advantageous embodiment, the body is adjustable in size andinvaginated in the patient's fundus stomach wall. As a result, the bodystretches the patient's stomach fundus wall when the size thereof isincreased, thereby creating satiety in a patient also suffering fromobesity. At least two implantable adjustable stretching devices may beprovided to stretch different parts of the patient's stomach wall, tothereby treat obesity by efficiently affecting the patient's appetite.The two stretching devices are suitably regulated from outside of thepatient's body, whereby a first of the stretching devices is regulatedat a first time to stretch a first part of the patient's stomach walland a second of the stretching devices is regulated at a second time tostretch a second part of the patient's stomach wall.

The stretching device may be hydraulically regulated. In this case, asubcutaneously implantable hydraulic reservoir connected to thehydraulic regulated stretching device may be provided, whereby thehydraulic regulated stretching device is non-invasively regulated bymanually pressing the hydraulic reservoir. Further, the movementrestriction device suitably includes an inflatable body, and a pump anda chamber in fluid contact with the body are provided, wherein the pumpregulates the hydraulic reservoir by pumping fluid or air from the bodyto the chamber.

The apparatus may include an implantable stimulation device that sendsout stimulation pulses to the cardia muscle to stimulate the cardiamuscle and thereby further close the cardia to additionally preventreflux disease. The stimulation device is comprised of at least oneconductor and at least one electrode that receives the stimulationpulses and applies them to the cardia muscle to thereby stimulate thecardia muscle. The at least one electrode may also be kept in place bythe stomach-oesophagal sutures or invagination in the stomach wall. Thestimulation pulses may be sent as a train of pulses, wherein the pulsetrain is repeated with a time break in between, the break extending thebreak between each pulse in the pulse train. The stimulation device mayinclude an electronic circuit and an energy source preferably adapted toincorporate the electronic circuit and energy source.

The stimulation device preferably comprises at least one sensor forsensing a physical parameter of the patient or a functional parameter ofthe movement restriction device and an internal control unit forcontrolling the stimulation device.

Normally, the internal control unit controls the stimulation device inresponse to information from the sensor.

A sensor sensing a contraction wave of the oesophagus, or any otherparameter correlated to food intake, sends the information to theinternal control unit and the internal control unit then ceases thestimulation in response to such information from the sensor.

The stimulation device may, at any time, be controlled by the patient.

Stimulation Device

The stimulation device of the apparatus will now be described.

The control device is operable by the patient to control the stimulationdevice to continuously alternate between an operation mode, in which thecardia sphincter is stimulated with energy pulses, and a rest mode, inwhich the cardia sphincter is not stimulated. (The term “patient”includes an animal or a human being.) The continuous alternation betweenthe operation and rest modes gives the advantage that the cardiasphincter is able to “recover” during the rest modes and as a result bemore sensitive during the operation modes. Another advantage is that theenergy consumption of the new apparatus will be considerably lower ascompared with the above-discussed prior continuous stimulation system.In addition, since the control device is operable by the patient he orshe may choose when the apparatus should be in operation. For example,for some patients it may be sufficient to keep the apparatus temporarily“on” when the patient feels reflux troubles, such as at night when thepatient is lying, others may need to have the apparatus all the time“on”, except when the patient eats.

In accordance with a preferred embodiment of the invention, theapparatus comprises a source of energy, wherein the control devicecontrols the source of energy to release energy for use in connectionwith the power of the stimulation device, when the stimulation device isimplanted. As a result, the apparatus of the invention provides a simpleand effective control of the energy supplied to implanted components ofthe apparatus, which ensures an extended and reliable functionality ofthe apparatus, possibly for the rest of the patient's life and at leastmany years.

In the preferred embodiment, the control device may be controllable fromoutside the patient's body to control the stimulation device to vary theintensity of the stimulation of the cardia sphincter over time. Morespecifically, the control device may be adapted to control thestimulation device to change the intensity of the stimulation of thecardia sphincter so that the cardia sphincter tonus is changed.

Preferably, the source of energy comprises an electric source of energyand the control device is adapted to control the electric source ofenergy to deliver electric pulses to the stimulation device. Animplantable switch for switching the delivery of electric pulses fromthe electric source of energy may be provided. The switch may bemanually operable by the patient, or, alternatively, the control devicemay comprise a wireless remote control operable by the patient tocontrol the switch.

Where the stimulation device stimulates the cardia sphincter withelectric pulses there may be a problem of providing a voltage intensitystrong enough to achieve the desired electric stimulation of the cardiasphincter. This is so because the intensity of the electric stimulationmight fade over time, due to increasing electric resistance caused bythe formation of fibrosis where electric conductors engage the cardiasphincter. This problem is solved by a main embodiment of the presentinvention, in which the stimulation device comprises electric conductorsfor engaging the cardia sphincter, the electric source of energy isadapted to provide a current through the electric conductors, and thecontrol device is adapted to control the electric source of energy torelease electric energy such that the intensity of the current throughthe electric conductors amounts to a predetermined value. As a result,decreasing current intensity caused by the formation of fibrosis wherethe conductors engage the cardia sphincter can be compensated for. Thus,if the current through the conductors decreases the control deviceautomatically controls the electric source of energy to release moreelectric energy to restore the desired current intensity.

Advantageously, the control device is adapted to control the electricsource of energy to release energy in the form of an alternatingcurrent. The inventor has found that unlike an alternating current adirect current could cause electrolysis in the cardia sphincter. Suchelectrolysis could injure the cardia sphincter.

All of the above embodiments may be combined with at least oneimplantable sensor for sensing at least one physical parameter of thepatient, wherein the control device may control the stimulation devicein response to signals from the sensor. In particular, the sensor maysense as the physical parameter the contraction wave in the esophaguscaused by the patient swallowing food. In this case the stimulationdevice is adapted to cease the stimulation of the cardia sphincter inresponse to the sensor sensing the contraction wave in the patient'sesophagus.

As an alternative, the sensor may comprise a pressure sensor fordirectly or indirectly sensing the pressure in the esophagus. Theexpression “indirectly sensing the pressure in the esophagus” should beunderstood to encompass the cases where the sensor senses the pressureagainst the stimulation device or human tissue of the patient.

The control device may comprise an internal control unit, preferablyincluding a microprocessor, to be implanted in the patient forcontrolling the stimulation device. The internal control unit maysuitably directly control the stimulation device in response to signalsfrom the sensor. In response to signals from the sensor, for examplepressure, the patient's position, the contraction wave in the patient'sesophagus or any other important physical parameter, the internalcontrol unit may send information thereon to outside the patient's body.The control unit may also automatically control the stimulation devicein response to signals from the sensor. For example, the control unitmay control the stimulation device to efficiently stimulate the cardiasphincter, such that the cardia for certain is completely closed inresponse to the sensor sensing that the patient is lying.

The control device may also, or alternatively, comprise an externalcontrol unit outside the patient's body, wherein the internal controlunit is programmable by the external control unit, for example forcontrolling the stimulation device over time. Alternatively, theinternal control unit may control the stimulation device over time inaccordance with an activity schedule program, which may be adapted tothe patient's needs.

The external control unit may also, suitably directly, control thestimulation device in response to signals from the sensor. The externalcontrol unit may store information on the physical parameter sensed bythe sensor and may be manually operated to control the stimulationdevice based on the stored information. In addition, there may be atleast one implantable sender for sending information on the physicalparameter sensed by the sensor.

A great advantage is that the patient is enabled to keep the cardiacompletely closed by means of the stimulation device by using thecontrol device whenever he likes during the day. This advantage shouldnot be underestimated, because in case the patient would need to vomitit would be very difficult for him to do so if he were unable toimmediately stop the stimulation of the cardia.

Conveniently, the external control unit may load the internal controlunit with data in accordance with a loading mode only authorised for adoctor. For specialised controls of the stimulation device, such aselectric power, electric pulse frequency etc, the external control unitmay control the internal control unit in accordance with a doctor modeonly authorised for the doctor. For simple controls of the stimulationdevice, such as “on” and “off”, the external control unit may controlthe internal control unit in accordance with a patient mode permittedfor the patient. Thus, by using the external control unit in accordancewith different modes it is possible to have certain functions of thestimulation device controlled by the patient and other more advancedfunctions controlled by the doctor, which enables a flexiblepost-operation treatment of the patient.

The control device may be adapted to control the source of energy torelease energy, for instance to intermittently release energy in theform of a train of energy pulses, for direct use in connection with thepower of the stimulation device. In accordance with a suitableembodiment the control device controls the source of energy to releaseelectric energy, and the apparatus further comprises an implantablecapacitor for producing the train of energy pulses from the releasedenergy. In this case the term “direct” is used to mean, on one hand,that the released energy is used while it is being released by thecontrol device, on the other hand, that the released energy may besomewhat delayed, in the order of seconds, by for instance an energystabiliser before being used in connection with the power of thestimulation device.

In accordance with an embodiment of the invention, the apparatuscomprises implantable electrical components including at least one, oronly one single voltage level guard and a capacitor or accumulator,wherein the charge and discharge of the capacitor or accumulator iscontrolled by use of the voltage level guard.

In one embodiment, the source of energy is external to the patient'sbody and the control device controls the source of energy to releasewireless energy. An energy storage device, preferably an electricaccumulator, may be implanted in the patient for storing the wirelessenergy released from the external source of energy. The electricaccumulator may comprise at least one capacitor or at least onerechargeable battery, or a combination of at least one capacitor and atleast one rechargeable battery. Alternatively, a battery may beimplanted in the patient for supplying electric energy to implantedelectric energy consuming components of the apparatus, in addition tothe supply of wireless energy. Where the control device comprises animplantable control unit the electronic circuit thereof and thestimulation device may be directly powered with transformed wirelessenergy, or energy from either the implanted energy storage device orbattery.

In one embodiment the wireless energy is directly used for the power ofthe stimulation device, i.e. the stimulation device is powered as thewireless energy is released from the external source of energy by thecontrol device. In this case the term “directly” is used to mean, on onehand, that the stimulation device is promptly powered by using thereleased energy whiteout first storing the latter, on the other hand,that the released energy may be somewhat delayed, in the order ofseconds, by for instance an energy stabiliser before being used for thepower of the stimulation device. As a result, a very simple control ofthe stimulation device is achieved and there are only a few implantedcomponents of the apparatus. For example, there is no implanted sourceof energy, such as a battery, nor any implanted complicated signalcontrol system. This gives the advantage that the apparatus will beextremely reliable.

In one embodiment, the source of energy comprises an implantableinternal source of energy. Thus, when the internal source of energy isimplanted in a patient the control device controls it from outside thepatient's body to release energy. This solution is advantageous forsophisticated embodiments of the apparatus that have a relatively highconsumption of energy that cannot be satisfied by direct supply ofwireless energy. The internal source of energy preferably comprises anelectric source of energy, such as an accumulator or a battery.Alternatively, the control device may be adapted to release wirelessenergy from the internal source of energy and to control the stimulationdevice to stimulate the patient's cardia sphincter with the releasedwireless energy. The wireless energy may comprise radiant energy orsound energy, such as ultrasound energy.

In one embodiment of the invention, the apparatus comprises a switchimplanted in the patient for directly or indirectly switching the powerof the stimulation device and an internal electric source of energy,such as a battery, implanted in the patient for supplying electricenergy for the power of the stimulation device, wherein the switchdirectly or indirectly affects the supply of electric energy from theinternal electric source of energy. This solution is advantageous forembodiments of the apparatus that have a relatively high consumption ofenergy that cannot be met by direct supply of wireless energy.

In one embodiment of the invention, the switch switches between an “off”mode, in which the internal electric source of energy is not in use, andan “on” mode, in which the internal electric source of energy supplieselectric energy for the power of the stimulation device. In this case,the switch is conveniently operated by the wireless energy released fromthe external source of energy to switch between the “on” and “off”modes. The control device, preferably comprising a wireless remotecontrol, may control the external source of energy to release thewireless energy. The advantage of this embodiment is that the lifetimeof the implanted electric source of energy, such as a battery, can besignificantly prolonged, since the implanted source of energy does notsupply energy when the switch is in its off mode.

In one embodiment, the control device comprises a wireless remotecontrol for controlling the internal electric source of energy. In thiscase, the switch is operable by the wireless energy from the externalsource of energy to switch between an “off” mode, in which the internalelectric source of energy and remote control are not in use, and a“standby” mode, in which the remote control is permitted to control theinternal electric source of energy to supply electric energy for thepower of the stimulation device.

In one embodiment, the apparatus further comprises an energytransforming device to be implanted in the patient for transforming thewireless energy into storable energy, and an implantable energy storagedevice for storing the storable energy, wherein the switch is operableby energy from the implanted energy storage device to switch between an“off” mode, in which the internal electric source of energy is not inuse, and an “on” mode, in which the internal electric source of energysupplies electric energy for the power of the stimulation device. Inthis case, the control device suitably comprises a wireless remotecontrol for controlling the energy storage device to operate the switch.

An external data communicator may be provided outside the patient's bodyand an internal data communicator to be implanted in the patient may beprovided for communicating with the external data communicator. Theinternal data communicator may feed data related to the patient, orrelated to the stimulation device, back to the external datacommunicator. Alternatively or in combination, the external datacommunicator may feed data to the internal data communicator. Theinternal data communicator may suitably feed data related to at leastone physical signal of the patient.

Suitably, an implantable stabiliser, such as a capacitor, a rechargeableaccumulator or the like, may be provided for stabilising the electricenergy released by the control device. In addition, the control devicemay control the source of energy to release energy for a determined timeperiod or in a determined number of energy pulses.

All of the above embodiments are preferably remote controlled. Thus, thecontrol device advantageously comprises a wireless remote controltransmitting at least one wireless control signal for controlling thestimulation device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need in a dailybasis, which is beneficial with respect to the treatment of the patient.

The wireless remote control may be capable of obtaining information onthe condition of the stimulation device and of controlling thestimulation device in response to the information. Also, The remotecontrol may be capable of sending information related to the stimulationdevice from inside the patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implantable in thepatient. In another particular embodiment of the invention, the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplantable in the patient.

The remote control may transmit a carrier signal for carrying thecontrol signal, wherein the carrier signal is frequency, amplitude orfrequency and amplitude modulated and is digital, analogue or digitaland analogue. Also the control signal used with the carrier signal maybe frequency, amplitude or frequency and amplitude modulated.

The control signal may comprise a wave signal, for example, a sound wavesignal, such as an ultrasound wave signal, an electromagnetic wavesignal, such as an infrared light signal, a visible light signal, anultra violet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, or a gamma radiation signal.Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analogue, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analogue control signal. For example, use of an analogue carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

The control device may be activated in a manual or non-manual manner tocontrol the source of energy to release energy.

In the above-presented embodiments of the invention the released energymay comprise electric energy and an implantable capacitor having acapacity less than 0.1 μF may be provided for producing theabove-mentioned train of energy pulses.

Generally, the wireless energy comprises a signal.

The apparatus may further comprise an implantable energy transformingdevice for transforming wireless energy, for example in the form ofsound waves, directly or indirectly into electric energy, for the powerof the stimulation device. More specifically, the energy transformingdevice may comprise a capacitor adapted to produce electric pulses fromthe transformed electric energy.

Generally, the stimulation device advantageously is embedded in a softor gel-like material, such as a silicone material having hardness lessthan 20 Shore.

The stimulation device may comprise a band for application around thecardia, wherein the band has electric conductors for contacting thecardia sphincter. The electric conductors may comprise hooks to securethe conductors on the cardia.

The present invention also provides a system for treating heartburn andreflux disease, comprising an implantable stimulation device adapted tostimulate the cardia sphincter of a patient to increase the sphinctertonus, and a control device that controls the stimulation device tocontinuously alternate between an operation mode, in which the cardiasphincter is stimulated with energy pulses, and a rest mode, in whichthe cardia sphincter is not stimulated. The energy pulses may compriseelectric pulses. The stimulation device may comprise electric conductorsfor engaging the cardia sphincter, and an electric source of energy maybe adapted to provide a current through the electric conductors to formthe electric pulses. Advantageously, the control device may control theelectric source of energy to release the electric energy such that thecurrent through the electric conductors amounts to a predeterminedvalue.

All the above described various components may be combined in thedifferent embodiments where applicable. Also the various functionsdescribed in connection with the above embodiments of the invention maybe used in different applications, where applicable.

All the various ways of transferring energy and controlling the energypresented in the present specification may be practised by using all ofthe various components and solutions described.

The present invention also provides methods for treating heartburn andreflux disease.

Accordingly, in accordance with a first alternative method, there isprovided a method of treating heartburn and reflux disease, comprisingthe steps of:

implanting an stimulation device in a patient, so that the stimulationdevice engages the cardia, and

controlling the stimulation device to continuously alternate between anoperation mode, in which the cardia sphincter is stimulated with energypulses to increase the sphincter tonus, so that the cardia completelycloses, and a rest mode, in which the cardia sphincter is notstimulated.

The first alternative method may also be performed laparoscopically.Thus, there may be provided a laparoscopic method of treating heartburnand reflux disease, comprising the steps of:

laparosopically implanting an stimulation device in a patient, so thatthe stimulation device engages the cardia, and

controlling the stimulation device to continuously alternate between anoperation mode, in which the cardia sphincter is stimulated with energypulses to increase the sphincter tonus, so that the cardia completelycloses, and a rest mode, in which the cardia sphincter is notstimulated.

In accordance with a second alternative method, there is provided amethod of treating a patient having heartburn and reflux disease,comprising:

(a) Surgically implanting in the patient an electric stimulation deviceengaging the cardia.

(b) Providing a source of energy external to the patient's body.

(c) Controlling the external source of energy from outside the patient'sbody to release wireless energy. And

(d) using the released wireless energy in connection with the poweringof the stimulation device.

The second alternative method may further comprise implanting an energytransforming device, controlling the external source of energy torelease wireless energy, and transforming the wireless energy by theenergy transforming device into energy different from the wirelessenergy for use in connection with the power of the stimulation device.This method may further comprise implanting a stabiliser in the patientfor stabilising the energy transformed by the energy-transformingdevice.

There is also provided a method of treating heartburn and refluxdisease, comprising the steps of:

implanting a stimulation device in a patient to engage the cardiasphincter, providing a control device for controlling the stimulationdevice to stimulate the cardia sphincter to increase the sphinctertonus, so that the cardia completely closes, and

permitting the patient to operate the control device to vary theintensity of the stimulation.

In one embodiment there is provided an apparatus where the stimulationof the cardia sphincter is made with energy pulses to increase thesphincter tonus so that the cardia completely closes and said controldevice is operable by the patient in that it can be set out ofoperation, wherein the control device is further operable by the patientto set the stimulation device into operation, in which operational statethe stimulation device continuously alternates between an operationmode, in which the cardia sphincter is stimulated with said energypulses, and a rest mode, in which the cardia sphincter is notstimulated, wherein the apparatus further comprises at least oneimplantable sensor for sensing at least one physical parameter of thepatient, wherein the control device is adapted to control thestimulation device to cease the continuous alternation between theoperation mode and the rest mode and to put the stimulation device inthe rest mode in response to the sensor sensing the physical parameterof the patient.

In one embodiment there is provided an apparatus where the stimulationof the cardia sphincter is made with energy pulses to increase thesphincter tonus so that the cardia completely closes and said controldevice is operable by the patient in that it can be set out ofoperation, wherein the control device is further operable by the patientto set the stimulation device into operation, in which operational statethe stimulation device continuously alternates between an operationmode, in which the cardia sphincter is stimulated with said energypulses, and a rest mode, in which the cardia sphincter is notstimulated, wherein the apparatus further comprises at least oneimplantable sensor for sensing as a physical parameter of the patient atleast the contraction wave in the esophagus caused by the patientswallowing food, wherein the control device is adapted to control thestimulation device to cease the continuous alternation between theoperation mode and the rest mode and to put the stimulation device inthe rest mode in response to the sensor sensing the contraction wave inthe patient's esophagus.

Surface Structure

The surface structure of the various implants of the invention will nowbe described.

The present invention concerns an implant, adapted to post-operativelybe adjustable and comprising at least one expandable section, whereinthe implant is adapted to be adjustable between a first collapsed stateand a second expanded state. In the first collapsed state the expandablesection is collapsed, and in the second expanded state, the expandablesection is expanded. The outer surface of said expandable section doesat least partly comprise a surface structure having elevated areasalternating with lowered areas. The expandable section is adapted tohave, in at least one of said first collapsed and second expanded statesa first distance between adjacent elevated areas sufficiently extendedto prevent growth of fibrotic tissue from directly interconnectingadjacent elevated areas to an extent that compromises the adjustabilitybetween a first collapsed and a second expanded state of said implant.The expandable section further comprising connecting areas betweenadjacent elevated and lowered areas, further adapted to have, in atleast one of said first collapsed and second expanded states, a seconddistance between adjacent connecting areas sufficiently extended toprevent growth of fibrotic tissue from directly interconnecting adjacentconnecting areas to an extent that compromises the adjustability betweena first collapsed and a second expanded state of said implant.

According to one embodiment the expandable section is hollow orcomprises a hollow body.

According to another embodiment the implant is substantially completelyhollow or comprises a hollow body extending along substantially thecomplete length and/or complete volume of said implant.

Fibrotic tissue can often have an extension or thickness of about 0.5 mmto about 1.5 mm and hence the distances between relevant surfaces of theelements of the surface structure are suitably greater than about 3 mm,hence greater than about 2×1.5 mm. But depending on the circumstancesalso distances greater than about 1.0 mm to about 3 mm may besufficient. In cases where the fibrotic tissue can be expected to havean extension or thickness greater than about 1.5 mm the distancesbetween relevant surfaces of the elements of the surface structure areadapted in a suitable manner.

The surface structure may comprise elevated and lowered areas and it maybe suitable that also a distance between the different planes of theelevated and lowered areas is bigger than a certain threshold tofacilitate the collapsible and/or expandable functionality of theimplant. If said distance is too small, the collapsible and/orexpandable functionality of the implant may be limited. A suitableinterval for said distance is around 0.5 to 10 mm, more suitable around2-8 mm and most suitable around 3-7 mm The surface structure maycomprise different geometrical elements or shapes and any combination ofsuch elements or shapes as long as the above mentioned conditions forthe distances can be met. The surface structure may e.g. comprise ridgesand grooves of different shapes. The ridges and grooves may each have across-section that is e.g. wedge-shaped, polygonal, square-formed,pyramidal-shaped, truncated pyramidal-shaped or. Further may the ridgesand grooves have cross-sections of different shapes. The surfacestructure may as well in general comprise a bellows-shaped structure ora surface structure where geometrical objects of the same or differentkind(s) are placed on a surface. The geometrical objects may bepractically randomly placed on the surface or according to some scheme.

One type of implants where this type of surface structure may besuitable, is implants where the implant should have the ability tochange shape and/or size substantially. Hence, this is a case where thepresence of fibrotic tissue substantially could hinder or impede thefunction of the implant. But the surface structure may be used by anyimplant where the characteristics of the surface structure would beadvantageous for the implant.

Combination with Obesity Treatment

The various embodiments can be combined with various methods fortreating obesity. In particular two embodiments, one comprising astretching device and one comprising a volume filling device, will bedescribed below.

Stretching Device for Treating Obesity

In addition the various embodiments the apparatus for treating refluxcan be combined with a device for the treatment of obesity that that isbased on the realization that by creating a stretching effect of thestomach wall a feeling of satiety is created. By means of providing anapparatus with a stretching device stretching part of the stomach wall,a simpler, safer and long term working apparatus is provided.

The expression “powered” should be understood as energised witheverything without manual force, preferably electric energy. In otherwords, the adjustment device is operated in a non-manual manner. Theexpression “non-manual manner” should be understood to mean that theadjustment device is not operated by manually touching subcutaneouslyimplanted components of the apparatus or not manipulated by touching theskin of the patient. Thus, as opposed to prior practice when treatinganal incontinence, the adjustment device of the invention is notoperated by manual forces, such as by manually compressing a fluidcontaining balloon implanted in the scrotum or in the region of labiamajora. Of course, manual manipulation of an implanted reservoir orother mechanical or hydraulic solutions may also be used as well asmanual manipulation of a subcutaneous start button or the like foractivating the powered operation device everything is permitted withinthe scope of the present invention.

Alternatively, or preferably in combination with a powered operationdevice, the servo means may be used, which enables for example a motorto run with high speed and low force and with for example a gear box todecrease the speed and increase the force or torque. The servo means maycomprise hydraulic means, electric control means, magnetic means, ormechanical means, which may be activated by manual manipulating meansand/or remote control. Using a servo system will save the use of forcewhen adjusting the adjustment device, which may be of importance in manyapplications.

The term “servo means” encompasses the normal definition of a servomechanism, i.e. an automatic device that controls large amounts of powerby means of very small amounts of power, but may alternatively oradditionally encompass the definition of a mechanism that transfers aweak force acting on a moving element having a long stroke into a strongforce acting on another moving element having a short stroke. The servomeans may comprise a motor, preferably an electric motor, which may bereversible.

Alternatively, or preferably in combination with a manual manipulation,a reversed servo means may be used, which enables for example a thepatients hand to use a higher force to with for example manipulate ahydraulic reservoir to move a small amount of fluid with strong force tocontrol a larger movement of fluid. The reversed servo means maycomprise hydraulic means, electric control means, magnetic means, ormechanical means, which may be activated by manual manipulating meansand/or remote controlled. Using a reversed servo system will save theuse of stroke when adjusting the adjustment device, which may be ofimportance in many applications.

The term “reversed servo means” encompasses the definition of an devicethat is controlled with a higher force and a small stroke i.e. forexample movement of a small amount of fluid with a high force controls alarger amount of fluid moving by means of very smaller force, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a strong force acting on a moving element having a shortstroke into a small force acting on another moving element having a longstroke. The reversed servo means is preferably used when manual controlof the device through intact skin is possible.

In general, two points on the stomach wall should be moved in relationto each other and away from each other to cause distension of a smallpart of the stomach wall, thereby causing satiety. This could be done inmany different ways. On way is to expand an invaginated deviceinvaginated in the stomach wall. Another way is to move two fixationpoints on the stomach wall. Of course first and second positions may besutured or fixated to the stomach wall in many possible ways and theinvention covers all possibilities to distend the stomach wall by movingtwo portions of the stomach wall away from each other and thereby afirst fixation of the device being moved in relation to a secondfixation, at least two positions on the stomach wall. However, the softsuspended connection to the stomach wall achieved by invaginating atleast one adapted part of the device is preferred, where fibroticstomach to stomach tissue helps to give a long term stable position.

Any kind of mechanical construction may be used. Any mechanicalconstruction driven mechanically or hydraulically or any pneumaticconstruction may be used. Any motor or any pump or moving materialchanging form when powered may be used to achieve the simple goal ofstretching a part of the stomach wall by moving at least two portions ofthe stomach wall away from each other.

Any kind of hydraulic operation may be used. It will be appreciated thatinstead of hydraulic operation, pneumatic operation can be used, whereinair instead of hydraulic fluid is moved between a reservoir and achamber formed by the stretching device. Preferably the reservoir has alocking position to keep it in the desired position if it is handled bythe patient. To compress the reservoir it preferably stays compressedand releases after pressing again.

Any kind of hydraulic solution may be used for the stretching device.The hydraulic solution may be driven by both mechanically and poweredwith any motor or pump as well as manual.

Of course just expanding an in-vaginated part of the stomach alsostretches away the stomach wall which also may be achieved bothmechanically, hydraulically, pneumatically and both being powered with amotor or pump or by manual force.

Volume Filling Device for Treating Obesity

In addition the various embodiments the apparatus for treating refluxcan be combined with a device for the treatment of obesity that is basedon implanting a volume filling device in the stomach that createssatiety.

The following embodiment is based on the realization that byinvaginating a volume filling device by the stomach wall of the patient,this inflatable object is protected from the stomach acids and will thusremain functioning for a very long time.

According to one embodiment of the invention, an apparatus to treatobesity and reflux of a patient having a stomach with a food cavity isprovided, the apparatus comprising at least one volume filling deviceadapted to be at least substantially invaginated by a stomach wallportion of the patient, wherein the volume filling device is adapted tobe placed on the outside of the stomach wall, so that the volume of thefood cavity is reduced in size by a volume substantially exceeding thevolume of the volume filling device, wherein the surface of the volumefilling device comprises a biocompatible material, wherein a substantialpart of the surface of the volume filling device is adapted to restagainst the outside of the stomach wall, and wherein the volume fillingdevice has a maximum circumference of at least 30 mm.

By invaginating the volume filling device by a stomach wall portion ofthe patient on the outside of the stomach wall, the volume fillingdevice is protected from the stomach acids, thereby providing a devicethat will last for a long time.

The volume filling device is adapted to be placed with the outer surfaceof the volume filling device resting against the stomach wall, such thatthe volume of the food cavity is reduced in size by a volumesubstantially exceeding the volume of the volume filling device. Thevolume filling device has a maximum circumference of at least 30millimeters. The apparatus further comprises an implantable movementrestriction device adapted to be at least partly invaginated by thepatient's stomach fundus wall and having an outer surface that includesa biocompatible material. A substantial part of the outer surface of themovement restriction device is adapted to rest against the stomach wallwithout injuring the latter in a position between the patient'sdiaphragm and at least a portion of the lower part of the invaginatedstomach fundus wall, such that movement of the cardiac notch of thepatient's stomach towards the patient's diaphragm is restricted, whenthe movement restriction device is invaginated, to thereby prevent thecardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen.The movement restriction device has a size of at least 125 mm³ and acircumference of at least 15 mm.

Accordingly, the apparatus of the present invention is well suited fortreating obesity of an obese patient, as well as reflux disease of thesame patient. This is advantageous, because reflux disease is a verycommon condition among human beings suffering from obesity.

In accordance with a first option, the volume filling device is adaptedto be placed inside the stomach with the outer surface of the volumefilling device resting against the inside of the stomach wall.

In accordance with a second option, the volume filling device is adaptedto be placed outside the stomach with the outer surface of the volumefilling device resting against the outside of the stomach wall.

Preferably, the volume filling device is adapted to be completelyinvaginated by the stomach wall of the patient and to be placed insideor outside the stomach wall via a gastroscopic instrument. To this endthe volume filling device may comprise an attachment device adapted toco-operate with a gripping instrument. Suitably, the volume fillingdevice is adapted to be non-invasively adjustable postoperatively.

The apparatus may comprise a fixation device, suitably two or morefixation devices, adapted to be involved in the fixation of the volumefilling device to the stomach wall. The volume filling device maycomprise a holding device adapted to be held by an instrument, suitablytwo or more holding devices, to simplify the implantation of the device.

At least a part of the volume filling device may be made of a materialwhich is not destructible by stomach acid. The volume filling device maybe destructible by acids, for example hydrochloric acid.

In an embodiment, the volume filling device is inflatable to an expandedstate and comprises an enclosure wall defining a chamber, wherein thevolume filling device is inflated with a gel or fluid supplied into thechamber. At least one tube may be connected to the volume filling devicefor supplying gel or fluid to the chamber. An injection port connectiblewith the tube may be provided. Alternatively, the volume filling membermay be provided with an inlet port for a fluid or a gel connectible to agastroscopic instrument, wherein the inlet port comprises a fluidconnection adapted to interconnect the inflatable device and thegastroscopic instrument.

The volume filling device may include a homogenous material, such as gelhaving a shure value of less than 15. The device may also be a solidbody.

The volume filling device may comprise a rigid, elastic or flexibleouter surface. Where the outer surface is rigid, it is rigid enough tomaintain non-deformed when subject to forces created by stomachmovements. The volume filling device may comprise a flexible non-elasticmaterial.

In accordance with a first general design of the volume filling device,the device has a maximum circumference as seen in a plane perpendicularto an axis through the device. The circumferences of the device as seenin other planes perpendicular to said axis are equal to the maximumcircumference or decrease as seen along said axis in the direction fromthe maximum circumference. For example, the device may be substantiallyegg shaped, spherically shaped, or substantially shaped like an egg withan indented middle section or like a bent egg.

In accordance with a second general design of the device, thecircumference of the device as seen in a plane perpendicular to an axisthrough the device increases and decreases at least two times as theplane is displaced along said axis, or decreases and increases at leastone time as the plane is displaced along said axis. For example, thedevice may be substantially shaped like a kidney.

The volume filling device have an elongated, rounded, bent and/or curvedshape.

The volume filling device has a circumference of at least 120, 150, 180or 220 mm.

The volume filling device has a volume in the range of 0.0001 to 0.001m³, or 0.00001 to 0.001 m³, or 0.00001 to 0.0002 m³. The volume of thevolume filling device has a volume of less than 0.0002 m³.

The volume filling device may comprise at least two interconnectableportions adapted to be placed inside or outside the stomach as separateportions.

The volume filling device may comprise an elastic material, abio-compatible material and/or silicone.

Suitably, the volume filling device is provided with a coating. Forexample, a Parylene coating, a polytetrafluoroethylene coating or apolyurethane coating. The coating may be a multi-layer coating. Thevolume filling device may comprise an outer surface layer ofpolyurethane, Teflon®, or PTFE, or a combination thereof.

The volume filling device may comprise a fluid adapted to be transformedinto solid state or fixed form. Such a fluid may be liquid polyurethaneor iso-tonic. The fluid may comprises large molecules, such as iodinemolecules, to prevent diffusion.

The volume filling device may have a maximum circumference of at least50 millimeters, preferably at least 80 millimeters. Suitably, the volumefilling device is deformable to a maximum diameter, so as to beinsertable into a laparoscopic trocar.

Preferably, the volume filling device is adapted to be kept in place bystomach-to-stomach sutures or staples to invaginate the device in thestomach wall. Advantageously, the volume filling device has varyingcircumference to better be kept in place invaginated in the stomach wallof the patient. The stomach-to-stomach sutures or staples may beprovided with fixation portions exhibiting a structure adapted to be incontact with the stomach wall to promote growth in of human tissue tosecure long term placement of the volume filling device attached to thestomach wall. The structure may comprise a net like structure.

In embodiment of the invention, the apparatus comprises a stretchingdevice placed outside the stomach wall and adapted to stretch a portionof the stomach wall, thereby affecting the patient's appetite. Where thevolume filling device is inflatable, the apparatus may comprise a fluidconnection interconnecting the stretching device and the volume fillingdevice.

In an embodiment of the invention, the apparatus comprises animplantable first fixation device that secures the movement restrictiondevice in a position that restricts the movement of the cardiac notch ofthe stomach towards the patient's diaphragm, with the outer surface ofthe movement restriction device substantially contacting the patient'sstomach fundus wall. The first fixation device may include sutures orstaples that attach together portions of the fundus stomach wall thatenclose the movement restriction device to secure the movementrestriction device in said position. I.e., the movement restrictiondevice is at least partly placed in an invaginated space. Thus, byaffixing the implantable movement restriction device indirectly in thismanner, no suturing between the movement restriction device and tissueis required, which, in turn, further reduces the risk for complications.Keeping the movement restriction device in place in this manner hasresulted in an elastic suspension with improved long term properties.

The first fixation device, such as sutures or staplers, attach togetherportions of the fundus stomach wall so at to invaginate the movementrestriction device from either inside or outside of the patient'sstomach wall.

In an alternative embodiment, a tissue growth promoting structure may besutured to the stomach wall with a relatively large contact surfacetowards the stomach. The relatively large surface of the structure, suchas a net, will allow for in-growth of human tissue for holding themovement restriction device in place over the long term. The tissuegrowth promoting structure may comprise sutures or staples that attachthe net like structure to the fundus stomach wall.

In addition to affixing the movement restriction device to the stomachwall a second fixation device may be employed. The second fixationdevice can be used to affix the movement restriction device in relationto the cardia. For example, the movement restriction device can beaffixed in a position above the cardia between the cardia and thediaphragm muscle, by a second direct or indirect affixation of themovement restriction device via the fundus stomach wall. The secondfixation device may secure, indirectly or directly, the movementrestriction device to the oesophagus close to the patient's angle ofHis. The second fixation device suitably includes a plurality of suturesor staples that attach the fundus wall and a wall of the patient'soesophagus to hold the movement restriction device in said position.

The apparatus may also comprise a third fixation device that secures,indirectly or directly, the movement restriction device to the patient'sdiaphragm muscle or associated muscles. The third fixation devicesuitably comprises a plurality of sutures or staples that attach thefundus wall and the diaphragm muscle or associated muscles to hold themovement restriction device in said position.

The movement restriction device may be adapted to be substantially orcompletely invaginated by the patient's stomach fundus wall and beplaced either on the inside or outside of the stomach fundus wall.

The movement restriction device may be adapted to be placed on theoutside of the patient's stomach wall, such that the stomach cavity issubstantially reduced, by a volume substantially exceeding the volume ofthe movement restriction device.

At least a part of the movement restriction device may be made of amaterial which is destructible or not destructible by stomach acid.

In an embodiment, the movement restriction device is inflatable andadapted to be inflated with a gel or fluid.

A fluid or gel receiving member for receiving fluid to inflate themovement restriction device may be provided.

The movement restriction device may include a homogenous material andmay be a solid body.

The movement restriction device may include an enclosure wall defining achamber.

The movement restriction device may have a rigid, elastic or flexibleouter wall. Where the outer wall is rigid, it is rigid enough tomaintain non-deformed when subject to forces created by stomachmovements.

In accordance with a preferred embodiment of the apparatus, the movementrestriction device comprises a body adapted to be at least partlyinvaginated by the patient's stomach fundus wall and having an outersurface that includes a biocompatible material. A substantial part ofthe outer surface of the body is adapted to rest against the stomachwall in said position between the patient's diaphragm and the portion ofthe lower part of the invaginated stomach fundus wall. Suitably, thebody is made of a material softer than 25 or 15 shure.

In accordance with a first general design of the body, the body has amaximum circumference as seen in a plane perpendicular to an axisthrough the body. The circumferences of the body as seen in other planesperpendicular to said axis are equal to the maximum circumference ordecrease as seen along said axis in the direction from the maximumcircumference. For example, the body may be substantially egg shaped,spherically shaped, or substantially shaped like an egg with an indentedmiddle section or like a bent egg.

In accordance with a second general design of the body, thecircumference of the body as seen in a plane perpendicular to an axisthrough the body increases and decreases at least two times as the planeis displaced along said axis, or decreases and increases at least onetime as the plane is displaced along said axis. For example, the bodymay be substantially shaped like a kidney.

Preferably, the body is dimensioned with a size larger than theintestinal outlet from the stomach. The body may have a smallest outerdiameter of 30 or 40 mm or larger and may have a smallest outercircumference of 150, 110, 90, 70, 50 or 30 mm.

Suitably, the body has rounded contours without too sharp edges thatwould be damaging to the patient's stomach wall, and has a generallysmooth outer surface for resting against the fundus wall.

The body is implantable either inside or outside of the patient'sstomach and is adapted to be attached to the patient's stomach wall bysurgery. The body may be changeable to assume a slender form having asmaller diameter than that of a trocar for laparoscopic use, whereby thebody when changed to said slender form can be pushed or pulled throughthe trocar. The body may include a flexible outer wall defining achamber filled with a fluid, such as a gel, allowing the body to passthrough such a trocar. Alternatively, the body may include an elasticcompressible material, allowing the body to pass through a trocar.

The body may be hollow and include at least two separate pieces adaptedto be inserted into the hollow body, and further adapted to be puttogether to one unitary piece inside the body, thereby allowing the bodyto pass through a trocar for laparoscopic use. Alternatively, the bodymay include an outer wall and a hollow compressed inner part, for beingfilled with a fluid or gel after insertion into the patient's body.

The body may include a chamber with an injection port, wherein thechamber of the body is filled with a fluid through the injection port.

The body may include at least one holding device adapted to be used forpushing or pulling the body through a trocar for laparoscopic use. Theholding device is adapted to hold a prolongation of the body that isadapted to be held by a surgical instrument. More specifically, theholding device is adapted to hold a thread or band inserted through theholding device. Where the body comprises an outer wall the holdingdevice is at least partly placed inside the outer wall of the body.

In an advantageous embodiment, the body is adjustable in size andinvaginated in the patient's fundus stomach wall. As a result, the bodystretches the patient's stomach fundus wall when the size thereof isincreased, thereby creating satiety in a patient also suffering fromobesity. At least two implantable adjustable stretching devices may beprovided to stretch different parts of the patient's stomach wall, tothereby treat obesity by efficiently affecting the patient's appetite.The two stretching devices are suitably regulated from outside of thepatient's body, whereby a first of the stretching devices is regulatedat a first time to stretch a first part of the patient's stomach walland a second of the stretching devices is regulated at a second time tostretch a second part of the patient's stomach wall.

The stretching device may be hydraulically regulated. In this case, asubcutaneously implantable hydraulic reservoir connected to thehydraulic regulated stretching device may be provided, whereby thehydraulic regulated stretching device is non-invasively regulated bymanually pressing the hydraulic reservoir. Further, the movementrestriction device suitably includes an inflatable body, and a pump anda chamber in fluid contact with the body are provided, wherein the pumpregulates the hydraulic reservoir by pumping fluid or air from the bodyto the chamber.

The apparatus may include an implantable stimulation device that sendsout stimulation pulses to the cardia muscle to stimulate the cardiamuscle and thereby further close the cardia to additionally preventreflux disease. The stimulation device is comprised of at least oneconductor and at least one electrode that receives the stimulationpulses and applies them to the cardia muscle to thereby stimulate thecardia muscle. The at least one electrode may also be kept in place bythe stomach-oesophagal sutures or invagination in the stomach wall. Thestimulation pulses may be sent as a train of pulses, wherein the pulsetrain is repeated with a time break in between, the break extending thebreak between each pulse in the pulse train. The stimulation device mayinclude an electronic circuit and an energy source preferably adapted toincorporate the electronic circuit and energy source.

The stimulation device preferably comprises at least one sensor forsensing a physical parameter of the patient or a functional parameter ofthe movement restriction device and an internal control unit forcontrolling the stimulation device.

Normally, the internal control unit controls the stimulation device inresponse to information from the sensor.

A sensor sensing a contraction wave of the oesophagus, or any otherparameter correlated to food intake, sends the information to theinternal control unit and the internal control unit then ceases thestimulation in response to such information from the sensor.

The stimulation device may, at any time, be controlled by the patient.

SUMMARY

Suitably, one of the layers may be made of made of metal, silicon orPTFE. The coating may be is a metal coating.

In an embodiment, the apparatus comprises a stretching device comprisingat least one operable stretching device implantable in an obese patientand adapted to stretch a portion of the patient's stomach wall and anoperation device for operating the stretching device when implanted tostretch the stomach wall portion such that satiety is created.

In an embodiment, the apparatus comprises at least one operablestretching device implantable in the patient and adapted to stretch aportion of the patient's stomach wall, and an implantable control unitfor automatically controlling the operable stretching device, when thecontrol unit and stretching device are implanted, to stretch the stomachwall portion in connection with the patient eating such that satiety iscreated.

In an embodiment, the apparatus comprises a stretching device comprisingat least one operable stretching device implantable in an obese patientand adapted to stretch a portion of the patient's stomach wall, whereinsaid stretching device comprising an expandable stretching reservoir andan operation device for operating the stretching device when implantedto stretch the stomach wall portion, wherein the volume filling deviceis inflatable and in fluid connection with said stretching reservoir,wherein said operation device comprises a pump for pumping fluid betweensaid main reservoir and said stretching reservoir to stretch saidstomach wall portion such that satiety is created. A control device maybe provided for controlling said stretching device including said pump.The control device may comprise a wireless remote control adapted tocontrol the stretching device from the outside of the patient's body, oran implantable control unit for controlling said stretching device.Alternatively, the control device may comprise a subcutaneously placedswitch or reservoir adapted to control the stretching device from theoutside of the patient's body. A sensor or sensing device to beimplanted in the patient body may be provided, wherein the implantablecontrol unit is adapted to control the stretching device from the insideof the patient's body using information from said a sensor or sensingdevice, adapted to sense, direct or indirect, the food intake of thepatient.

In an embodiment, the volume filling device comprises a main volumefilling reservoir, a stretching device comprising at least one operablestretching device implantable in an obese patient and adapted to stretcha portion of the patient's stomach wall, wherein said stretching devicecomprising an expandable reservoir, adapted to be invaginated in thestomach wall at the upper part of the stomach, higher up than theinflatable main volume filling device when the patient is standing,wherein the volume filling device is inflatable and in fluid connectionwith said stretching reservoir, wherein normal contractions of thestomach wall, related to food intake, cause fluid to flow from saidinvaginated main volume filling reservoir lower placed onto the stomachwall adapted to cause said stretching reservoir to stretch said stomachwall portion such that satiety is created. The fluid connection betweenthe main volume filling device reservoir and the stretching reservoircomprises a non-return valve. The fluid connection between the mainvolume filling device reservoir and the stretching reservoir comprises arelease function adapted to release the volume in the stretchingreservoir back to the main volume filling device reservoir. Said releasefunction may comprise a fluid return connection of a substantiallysmaller area than said fluid connection, to slowly release back fluid tosaid main volume filling device reservoir from the stretching reservoirto release said stretching of the stomach wall portion. A further manualcontrol device comprising a subcutaneously placed reservoir adapted tocontrol the stretching device from the outside of the patient's body maybe provided to further affect the stretching device to stretch thestomach wall portion.

In an embodiment, the a main volume filling device reservoir adapted tobe inflatable may be provided, wherein the volume filling device furthercomprises an expandable structure, adapted to expand, when the device isinvaginated in the stomach wall, wherein said structure comprising abellow adapted to take into account the fibrosis surrounding the devicewhen implanted, such that the movement of the bellow is substantiallyun-affected of said fibrosis.

In an embodiment, the apparatus comprises a stretching device comprisingat least one operable stretching device implantable in an obese patientand adapted to stretch a portion of the patient's stomach wall andwherein the stretching device comprising a expandable structure, adaptedto expand and stretch the stomach wall portion, when the device isinvaginated in the stomach wall, wherein said structure comprising aspecial bellow adapted to take into account the fibrosis surrounding thedevice when implanted, such that the movement of the bellow issubstantially un-affected of said fibrosis. An operation device foroperating the stretching device may be provided to stretch the stomachwall portion such that satiety is created. The apparatus may comprise animplantable control unit for automatically controlling the operablestretching device, when the control unit and stretching device areimplanted, to stretch the stomach wall portion in connection with thepatient eating such that satiety is created.

In an embodiment, the apparatus comprises a stretching device comprisingat least one operable stretching device implantable in an obese patientand adapted to stretch a portion of the patient's stomach wall such thatsatiety is created. The control device may comprise a wireless remotecontrol adapted to control the stretching device from the outside of thepatient's body or an implantable control unit for controlling saidstretching device. Alternatively, said control device may comprise asubcutaneously placed switch or reservoir adapted to control thestretching device from the outside of the patient's body. A sensor orsensing device adapted to be implanted in the patient body may beprovided, wherein the implantable control unit is adapted to control thestretching device from the inside of the patient's body usinginformation from said sensor or sensing device, adapted to sense, director indirect, the food intake of the patient.

In an embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable movementrestriction device adapted to be at least partly invaginated by thepatient's stomach fundus wall and having an outer surface that includesa biocompatible material, wherein a substantial part of the outersurface of the movement restriction device is adapted to rest againstthe stomach wall without injuring the latter in a position between thepatient's diaphragm and at least a portion of the lower part of theinvaginated stomach fundus wall, such that movement of the cardiac notchof the patient's stomach towards the patient's diaphragm is restricted,when the movement restriction device is invaginated, to thereby preventthe cardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen,the movement restriction device having a size of at least 125 mm³ and acircumference of at least 15 mm.

In another embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable movementrestriction device having an outer surface including a biocompatiblematerial, wherein the movement restriction device is adapted to restwith at least a part of its outer surface against the patient's stomachfundus wall, in a position between the patient's diaphragm and thefundus wall, such that movement of the cardiac notch of the patient'sstomach towards the patient's diaphragm is restricted, when the movementrestriction device is implanted in the patient, to thereby prevent thecardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen,wherein the movement restriction device having a size of at least 125mm³ and a circumference of at least 15 mm, and an affixation deviceadapted to secure the movement restriction device in said position, whenthe movement restriction device is implanted.

In another embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable movementrestriction device adapted to be at least partly invaginated by thepatient's stomach fundus wall and having an outer surface that includesa biocompatible material wherein a substantial part of the outer surfaceof the movement restriction device is adapted to rest against thestomach wall without injuring the latter in a position between thepatient's diaphragm and at least a portion of the lower part of theinvaginated stomach fundus wall, such that movement of the cardiac notchof the patient's stomach towards the patient's diaphragm is restricted,when the movement restriction device is invaginated, to thereby preventthe cardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen,the movement restriction device having a size of at least 125 mm³ and acircumference of at least 15 mm, further comprising a stretching devicecomprising at least one operable stretching device implantable in theobese patient and adapted to stretch a portion of the patient's stomachwall such that satiety is created.

In another embodiment, the apparatus is further adapted to treat refluxdisease. To this end, it further comprises an implantable movementrestriction device having an outer surface including a biocompatiblematerial, wherein the movement restriction device is adapted to restwith at least a part of its outer surface against the patient's stomachfundus wall, in a position between the patient's diaphragm and thefundus wall, such that movement of the cardiac notch of the patient'sstomach towards the patient's diaphragm is restricted, when the movementrestriction device is implanted in the patient, to thereby prevent thecardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain the supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen,wherein the movement restriction device having a size of at least 125mm³ and a circumference of at least 15 mm, and a fixation device adaptedto secure the movement restriction device in said position, when themovement restriction device is implanted, further comprising astretching device comprising at least one operable stretching deviceimplantable in the obese patient and adapted to stretch a portion of thepatient's stomach wall such that satiety is created.

In an embodiment, the apparatus further comprises a stretching devicecomprising three or more mechanical parts engaged with different partsof the stomach wall, one part each, wherein said engagement includessuturing or stapling to the stomach wall or invaginating the mechanicalparts in the stomach wall part with stomach to stomach sutures, whereinthe three or more mechanical parts are adapted to move in relation toeach other adapted to stretch three different wall portions, thestretching device further adapted to having said wall portions stretchedindependently from each other both regarding force used for stretchingthe stomach wall portion as well as, time periods the stretching isapplied, and when the stretching is applied.

In an embodiment, the apparatus further comprises a stretching devicecomprising two or more hydraulic parts engaged with different parts ofthe stomach wall, one part each, wherein said engagement includessuturing or stapling to hydraulic part to the stomach wall orinvaginating the hydraulic parts in the stomach wall part, with stomachto stomach sutures, wherein the two or more hydraulic parts are adaptedto move in relation to each other adapted to stretch three differentwall portions, the stretching device further adapted to having said wallportions stretched independently from each other both regarding forceused for stretching the stomach wall portion as well as, time periodsthe stretching is applied, and when the stretching is applied.

In an embodiment, the apparatus further comprises a stretching device isengaged with a part of the stomach wall, including suturing or staplingthe stretching device to the stomach wall or invaginating the stretchingdevice in the stomach wall part, with stomach to stomach sutures,wherein the stretching device is further adapted to stretch a stomachwall portion controlling force used for stretching the stomach wallportion as well as, time periods the stretching is applied, and when thestretching is applied.

In an embodiment, the apparatus further comprises a stretching devicecomprising two parts engaged with different parts of the stomach wall,one part each, wherein said engagement includes suturing or stapling theparts to the stomach wall or invaginating the parts in the stomach wallpart, with stomach to stomach sutures, wherein the stretching devicefurther adapted to have different wall portions stretched independentlyfrom each other controlling force used for stretching the stomach wallportion as well as, time periods the stretching is applied, and when thestretching is applied.

In an embodiment, the apparatus further comprises an external controlunit for controlling the volume filling device from the outside of thepatient's body. The external control unit may comprise a wireless remotecontrol adapted to control the device from the outside of the patient'sbody. Alternatively, the external control unit may comprise asubcutaneously placed switch or reservoir adapted to control the devicefrom the outside of the patient's body.

In an embodiment, the apparatus further comprises a sensor or sensingdevice adapted to be implanted in the patient body, wherein theimplantable control unit is adapted to control the device from theinside of the patient's body using information from said a sensor orsensing device, adapted to sense, direct or indirect, the food intake ofthe patient.

In accordance with another aspect of the present invention, there isprovided an apparatus for treating obesity of an obese patient having astomach with a food cavity, the apparatus comprising at least one volumefilling device adapted to be at least substantially invaginated by astomach wall portion of the patient and having an outer surface thatincludes a biocompatible material, wherein the volume filling device isadapted to be placed inside the stomach with the outer surface of thevolume filling device resting against the inside of the stomach wall,such that the volume of the food cavity is reduced in size by a volumesubstantially exceeding the volume of the volume filling device, thevolume filling device having a maximum circumference of at least 30millimeters.

Please note that any embodiment or part of embodiment or feature ormethod or associated system or part of system described herein may becombined in any combination.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples, and with reference to the accompanying drawings,in which:

FIGS. 1A-C are schematic views of various embodiments of an apparatusfor treating Gastroesophageal Reflux Disease implanted in a humanpatient.

FIGS. 2A-B are schematic views of various embodiments of an apparatusfor treating Gastroesophageal Reflux Disease implanted in a humanpatient.

FIGS. 3A-B are schematic views of various embodiment of an apparatus fortreating Gastroesophageal Reflux Disease implanted in a human patient.

FIGS. 4A-D are schematic views of embodiments of an apparatus fortreating Gastro-esophageal Reflux Disease and obesity implanted in ahuman patient.

FIG. 5A-B is a schematic view of an embodiment of an apparatus fortreating Gastro-esophageal Reflux Disease implanted in a human patient.

FIGS. 6A-D and 7-9 show alternative shapes of a movement restrictiondevice for treating Gastroesophageal Reflux Disease adapted to beimplanted in a human patient.

FIG. 10 is an overall view of a patient with an implanted movementrestriction device for treating Gastroesophageal Reflux Disease.

FIGS. 11-27 are schematic views of various ways of powering an apparatusfor treating Gastroesophageal Reflux Disease.

FIGS. 28-34C are schematic views of various ways of arranging thehydraulic or pneumatic powering of an apparatus of the invention fortreating Gastroesophageal Reflux Disease.

FIG. 35 is a flowchart illustrating steps performed when implanting amovement restriction device for treating Gastroesophageal RefluxDisease.

FIGS. 36-41 shows methods for restoring the location of the cardia andthe fundus in a patient suffering from Gastroesophageal Reflux Disease.

FIGS. 42-46 show different shapes and features of a reflux treatmentdevice comprised in an apparatus according to the invention,

FIGS. 47a-d show a deflated inflatable reflux treatment device comprisedin an apparatus according to the invention and an instrument for placingthe reflux treatment device on the outside of the stomach wall of thepatient.

FIGS. 48a-i illustrate different steps of invaginating the inflatabledevice of FIG. 47a on the outside of a stomach wall of a patient,

FIG. 49 shows an embodiment wherein the reflux treatment apparatus isalso adapted to treat obesity.

FIGS. 50-51-3 i show an embodiment wherein the reflux treatmentapparatus adapted also for treating obesity.

FIGS. 52a-h illustrate different steps of invaginating the inflatabledevice of FIG. 47a on the inside of a stomach wall of a patient,

FIGS. 53a-c shows an instrument for creating an invagination of the wallof the stomach.

FIGS. 54-55 show an abdominal method for treating reflux disease.

FIG. 56 is a schematic block diagram illustrating an embodiment of thereflux disease apparatus of the invention, in which wireless energy isreleased from an external source of energy for use in the power of astimulation device:

FIG. 57 is a schematic block diagram illustrating another embodiment ofthe invention, in which wireless energy is released from an internalsource of energy:

FIGS. 58 to 61 are schematic block diagrams illustrating fourembodiments, respectively, of the invention, in which a switch isimplanted in the patient for directly or indirectly switching the powerof the stimulation device;

FIG. 62 is a schematic block diagram illustrating conceivablecombinations of implantable components for achieving variouscommunication options;

FIG. 63 illustrates the apparatus in accordance with the inventionimplanted in a patient; and

FIG. 64 is a block diagram illustrating remote control components of anembodiment of the invention.

FIGS. 65-68 i are views of embodiments of an apparatus for treatingobesity by stretching the wall of the stomach that can be combined thereflux treatment apparatus implanted in a human patient.

FIG. 69a-k is a general description of the surface structure of anyimplanted device of the invention.

FIG. 70a-76c are views of various embodiments of an apparatus fortreating obesity that can be combined with the reflux treatmentapparatus implanted in a human patient.

FIGS. 77-93 show various ways of powering an apparatus for treatingobesity that can be combined with an apparatus for treating refluximplanted in a human patient.

FIGS. 94-100 c show various ways of arranging hydraulic or pneumaticpowering of an apparatus for treating obesity implanted in a humanpatient.

FIGS. 101a-105b show various instruments for treating reflux andobesity.

FIGS. 106-107 show methods for surgery for treating reflux and obesity.

DETAILED DESCRIPTION OF THE DRAWINGS Movement Restriction Device

FIG. 1A is a schematic view depicting an apparatus 11, including amovement restriction device 10 of a biocompatible material, for treatingreflux disease, in accordance with the invention, implanted in a humanpatient. In FIG. 1A, the device 10 is invaginated in the fundus. Thedevice 10 comprises a body 13 having an outer surface 15 suitable forresting against a portion of the outside wall 16 a of the stomach funduswall 16 in a position between the patient's diaphragm 18 and at least aportion of the lower part of the invaginated stomach fundus wall 16.Thus, with the device 10 invaginated in this fashion, movement of thecardiac notch of the patient's stomach towards the patient's diaphragmis restricted, thereby the cardia is prevented from sliding through thepatient's diaphragm opening into the patient's thorax 20 and thesupporting pressure against the patient's cardia sphincter muscleexerted from the patient's abdomen is maintained

The body 13 is inflatable and adapted to be inflated with a gel orfluid. A fluid or gel receiving member for receiving fluid to inflatesaid movement restriction device may be provided. Alternatively, thebody 13 includes a homogenous material and be a solid body.Alternatively, the body 13 includes an outer wall in the form of anenclosure wall defining a chamber. The outer wall may be rigid, elasticor flexible. Where the outer wall is rigid, it is rigid enough tomaintain non-deformed when subject to forces created by stomachmovements.

The body 13 of the movement restriction device 10 can be affixed to thewall 16 a of the fundus 16 in a number of different ways. In theembodiment shown in FIG. 1A, the device 10 is invaginated in the fundusstomach wall from outside the stomach. After invagination, a firstfixation device consisting of a number of stomach-to-stomach sutures orstaples 22 a is applied to keep the invagination in tact in the shortterm. This allows the growth of human tissue to keep the invagination intact over the long term.

There may optionally be a second fixation device consisting of a numberof sutures or staples 22 b that are provided between the wall 16 a ofthe fundus 16 and the wall 24 a of the oesophagus 24 to hold the device10 in said position between the patient's diaphragm 18 and at least aportion of the lower part of the invaginated stomach fundus wall 16.Thus, the device 10 is affixed in this position by this second fixationapparatus. A direct or indirect affixation of the device 10 to thediaphragm muscle 18 or associated muscles may be provided. As analternative, a direct or indirect affixation of the device 10 to theoesophagus His can be provided. Alternatively, or additionally, theremay be a third fixation device in the form of sutures or staples 22 cprovided between the wall 16 a of the fundus 16 and the diaphragm 18 tohold the device 10 in said position.

FIG. 1B shows an embodiment substantially similar to the one shown inFIG. 1A. In FIG. 1B the body 13 and invagiation are, in addition to theaffixation 22, fixed by means of sutures and/or staples 22 c between thereflux body 13 and the diaphragm 18, to hold the device in positionabove the cardia 14.

FIG. 1C shows another embodiment substantially similar to the one shownin FIG. 1A. In FIG. 1C the reflux treatment device is held in place bystomach-to-stomach sutures or staplers 22 a that connects the wall 16 aof the fundus 16 to the wall 16 a of the fundus 16. In addition thereflux treatment device 10 is held in place by sutures 22 b or staplersfrom the wall 16 of the fundus 16 a to the wall of the esophagus 24 a,and by sutures or staples from the wall of the fundus 16 a to thediaphragm.

An alternative embodiment of an apparatus 17 for the treatment of refluxdisease in accordance with the invention is depicted in FIG. 2A. Thisembodiment is, in many aspects, similar to the one described above withreference to FIG. 1A-C. Thus, a movement restriction device 10 is shownimplanted in a human patient and invaginated in the fundus. However, inthe embodiment shown in FIG. 2A, the device 10 is invaginated from theinside of the stomach, instead of from outside of the stomach, as inFIG. 1A-C. The movement restriction device 10 comprises a body 13adapted to rest against a portion of the inside wall of the stomachfundus wall 16 in a position between the patient's diaphragm 18 and atleast a portion of the lower part of the invaginated stomach fundus wall16. In this embodiment, the body 13 is situated above the cardia area 14of a standing human or animal mammal patient. The body 13 of the device10 is shaped to rest against the wall 16 a of the fundus 16, andfurther, has an outer surface 15 suitable to rest against this funduswall. Thus, with the device 10 invaginated in this fashion as describedabove in connection with FIG. 1A, movement of the cardiac notch of thepatient's stomach towards the patient's diaphragm is restricted, therebythe cardia is prevented from sliding through the patient's diaphragmopening into the patient's thorax 20 and the supporting pressure againstthe patient's cardia sphincter muscle exerted from the patient's abdomenis maintained.

After invagination, a number of stomach-to-stomach sutures or staples 33a comprising a first fixation device are applied from inside the stomach16 to keep the invagination in tact in the short term. This allows thegrowth of human tissue, keeping the invagination in tact over the longterm. Additional sutures or staples 22 b comprising a second fixationdevice can be provided between a wall portion 16 b of the fundus 16forming part of the invagination of the device 10 and the wall 24 a ofthe oesophagus 24 to hold the device 10 in said position. Similarly, athird fixation device in the form of sutures or staples 22 c can beprovided between another wall portion 16 c of the fundus 16 forming partof the invagination of the device 10 and the diaphragm 18 to hold thedevice 10 in said position.

An alternative embodiment is shown in FIG. 2B. This embodiment is inmany aspects similar to the one described with reference to FIG. 2A.However, here the sutures and staples 22 b and 33 a are all connected tothe fixator of the reflux treatment device 10. This embodiment lacksstomach-to-diaphragm sutures or staples.

An alternative an apparatus 19 for the treatment of reflux disease isdepicted in FIG. 3A. This alternative is in many aspects similar to theones described above with reference to FIGS. 1A-C and 2 A-B. Thus, amovement restriction device 10 is shown implanted in a human patient.The device 10 comprises a body 13 adapted to rest against a portion ofthe stomach fundus wall 16 in a position between the patient's diaphragm18 and stomach fundus wall 16. However, in this alternative, the device10 is not invaginated in the stomach 16. Instead, the affixation of thedevice 10 comprises an attachment structure 10 a, preferably a netlike-structure that is adapted to be in contact with the fundus stomachwall 16 a to promote the growth of human tissue to secure long termplacement of the reflux disease treatment device attached to the stomachwall. In the short term, a first fixation device in the form of suturesor staples 44 a may be provided between the attachment structure 10 aand the fundus wall 16 a to keep the attachment structure 10 a in place.

The attachment structure 10 a may be adapted for a second fixationdevice in the form of sutures or staples 44 b that are provided betweenthe wall 16 a of the fundus 16 and the wall 24 a of the oesophagus 24 tohold the device 10 in said position between the patient's diaphragm 18and stomach fundus wall 16. Similarly, the attachment structure 10 a mayalso be adapted for a third fixation device in the form of sutures orstaples 44 c that are provided between the wall 16 a of the fundus 16and the diaphragm 18, again, to hold the device 10 in said position.

An alternative embodiment is shown in FIG. 3B. This embodiment is inmany aspects similar to the one described with reference to FIG. 3A. Inthis embodiment the reflux treatment device 10 is, like in FIG. 2A-Binvaginated from the inside of the stomach. The attachment structure 10a is positioned on the wall 16 a of the fundus 16 above and around theinvagination created by the reflux treatment device 10.

A alternative embodiment of an apparatus 21 for treatment of refluxdisease in accordance with the invention is depicted in FIG. 4A. Thisembodiment is in many aspects similar to the one described above withreference to FIG. 1A-C. In FIG. 4A, a view of a device 10 for treatmentof reflux disease in accordance with the invention is shown implanted ina human patient. In FIG. 4A, the movement restriction device 10 is againinvaginated in the fundus 16. The device 10 comprises a body 13 havingan outer surface 15 suitable for resting against a portion of theoutside wall 16 a of the stomach fundus wall 16 in a position betweenthe patient's diaphragm 18 and at least a portion of the lower part ofthe invaginated stomach fundus wall 16. The body 13 is shaped to restagainst the outside wall 16 a of the fundus 16. Thus, with the device 10invaginated in this fashion, movement of the cardiac notch of thepatient's stomach towards the patient's diaphragm is restricted, therebythe cardia is prevented from sliding through the patient's diaphragmopening into the patient's thorax 20 and the supporting pressure againstthe patient's cardia sphincter muscle exerted from the patient's abdomenis maintained.

In the embodiment of FIG. 4A, as in the embodiment of FIG. 1A, afterinvagination of the device 10 in the fundus 16, a first fixation deviceconsisting of a number of stomach-to-stomach sutures or staples 22 a isapplied to keep the invagination in tact in the short term. A secondfixation device consisting of a number of sutures or staples 22 b isprovided to hold the device 10 in said position between the patient'sdiaphragm 18 and at least a portion of the lower part of the invaginatedstomach fundus wall 16. Additionally, a third fixation device in theform of sutures or staples 22 c may be provided between the wall 16 a ofthe fundus 16 and the diaphragm 18, again, to hold the device 10 in saidposition.

In the embodiment depicted in FIG. 4A, the size of the movementrestriction device 10 can be regulated while being implanted. The device10 is associated with a hydraulic reservoir 52 connected to the device10 by a lead 52 b, whereby a non-invasive regulation can be performed bymanually pressing the reservoir 52. The device 10 is, in turn, connectedto one or more smaller chambers 10 b.

Furthermore, the embodiment above may alternatively be used to alsotreat obesity. The apparatus may, in this embodiment, be adapted totreat obesity by using the volume of the movement restriction body 13 tocontain a fluid, and further using one or more smaller chambers 10 bconnected to the body 13 with a pump to be filled with fluid to stretchthe fundus wall to create satiety. The small chambers 10 b are alsoadapted to be invaginated to in the fundus stomach wall, and when filledwith fluid, an expansion occurs that results in human sensor feedbackcreating satiety. By placing the small hydraulic reservoir/pumpsubcutaneously in the patient, the patient is able to pump hydraulicfluid to fill the small chambers to feel full on request.

An alternative embodiment is shown in FIG. 4B. This embodiment issubstantially similar to the one shown in FIG. 4A but differs in how thereflux treatment device 10 and chambers 10 b are controlled. Here, thechambers 10 b are not controlled by a subcutaneous pump but a poweredinternal control unit 56. The internal control unit 56 comprises meansfor the patient to control the device 10 in how it shall be usedregarding treatment of reflux and/or obesity. It may also comprise meansof supplying power to the device.

The internal control unit 56 may comprise a battery 70, an electricswitch 72, a motor/pump 44, a reservoir 52, an injection port 1001. Anenergy transmission device 34 with a remote control is adapted forcontrolling and powering the device. The items being selected dependingon the circumstances, e.g. if the device is electrically, hydraulically,pneumatically or mechanically operated.

The control unit may receive input from any sensor 76, specially apressure sensor. Any type of sensor may be supplied. The internalcontrol unit 56 preferable includes intelligence in forms of a FPGA orMCU or ASIC or any other circuit, component or memory (For a moreextensive description see below under “system”).

FIG. 4C shows essentially the same as FIG. 4A with the difference thatthere is one small chamber 10 b instead of two small chambers as in 4A.FIG. 4C shows the small chamber 10 b in its empty state whereas FIG. 4Dshows the small chambers 10 b when it has been filled and enlarged tocreate satiety.

Yet an alternative embodiment of an apparatus 23 for the treatment ofreflux disease in accordance with the invention is depicted in FIG. 5A.This embodiment is, again, in many aspects similar to the one describedabove with reference to FIG. 1A-C. Thus, as in the embodiment of FIG.1A, a movement restriction device 10, which is invaginated in thefundus, is comprised of a body 13 having an outer surface 15 suitablefor resting against a portion of the outside wall 16 a of the stomachfundus wall 16 in a position between the patient's diaphragm 18 and atleast a portion of the lower part of the invaginated stomach fundus wall16. The body 13 of the device 10 is shaped to rest against the outsidewall 16 a of the fundus 16 and has a generally smooth outer surface 15suitable for resting against this fundus wall. And, again, afterinvagination of the device 10 in the fundus 16, a first fixation deviceconsisting of a number of stomach-to-stomach sutures or staples 22 a isapplied to keep the invagination in tact in the short term. A secondfixation device consisting of a number of sutures or staples 22 bapplied between the wall 16 a of the fundus 16 and the wall 24 a of theoesophagus 24 is provided to hold the device 10 in said position.

In the alternative embodiment shown in FIG. 5A, the apparatus 23 furthercomprises a stimulation device 26 for sending out stimulation pulsesadapted to stimulate the cardia muscle to further close the cardia toadditionally prevent reflux disease. The apparatus 23 comprises at leastone conductor 26 a and at least one electrode 26 b adapted to receivethe stimulation pulses.

The stimulation device 26 preferably comprises an electronic circuit andan energy source, which in the preferred embodiment is provided in thedevice 10.

The stimulation device 26 preferably sends stimulation pulses as a trainof pulses, wherein the pulse train is adapted to be repeated with a timebreak in between, the break extending the break between each pulse inthe pulse train.

FIG. 5B shows essentially the same embodiment as in FIG. 5A, with theaddition of an internal control unit 56, a remote control 28 and anexternal energy transmission device 34. The internal control unit 56 isconnected to the stimulation device with a power lead 56 b. The internalcontrol unit 57 may comprise a battery 70 and an electric switch 72 andother components described below under “system”.

The reflux disease treatment device 10 can, in accordance with oneembodiment of the present invention, be formed as a generally egg shapedbody, as is shown in FIG. 6A. The reflux disease treatment device 10can, in accordance with another embodiment of the present invention,also be formed as an egg or sphere shaped body with an indent in itsmiddle, as is shown in FIG. 6B. The reflux disease treatment device 10can, in accordance with yet another embodiment of the present invention,further be formed as a slightly bent egg shaped body as shown in FIG.6C.

The reflux disease treatment device 10 can, in accordance with a furtherembodiment of the present invention, be formed as a generallyspherically-shaped body, as shown in FIG. 6D.

As discussed above, the reflux treatment device 10 is fixed in aposition which is above the esophagus in a standing patient. To enablethis, one embodiment of the reflux treatment shown in FIG. 7 comprises afixator 10 d that may, for example, serve as an attachment point forsutures or staples. The fixator may be a loop or a ridge with or withoutholes or have any other shape that makes it suitable for fixating thereflux treatment device 10.

FIG. 8 show an embodiment of the reflux treatment device 10 where it isadjustable by a hydraulic mean, and 10 e is an injection port wherehydraulic fluid can be in order to expand the device. Alternatively, inone embodiment the reflux treatment device 10 can be inflated from asmall size to a larger size during a surgical procedure where it isadvantageous that the device is initially of small size, for exampleduring a laparoscopic procedure. In such an embodiment, any fillingmaterial, solid, liquid or gas many injected trough the injection port10 e in order for the reflux treatment device 10 to achieve its finalshape.

FIG. 9 shows an embodiment where the reflux treatment device 10 has asunken ridge 10 f adapted to being held with a surgical tool. This is tobe used, for example, during a surgical procedure when the refluxtreatment device is implanted.

When the reflux disease treatment device 10 is generally spherical,whereby it can be made to wholly or partly encompass the esophagus, theinner diameter D of the reflux disease treatment device 10, ispreferably such that it can encompass the esophagus and at least a partof the fundus so that the device does not rest directly against the wallof the esophagus when implanted.

The movement restriction device 10 may take any form that enables thedevice 10 to rest in a position in which movement of the cardiac notchof the patient's stomach towards the patient's diaphragm is restricted,thereby the cardia is prevented from sliding through the patient'sdiaphragm opening into the patient's thorax and the supporting pressureagainst the patient's cardia sphincter muscle exerted from the patient'sabdomen is maintained.

System

An energy and operation system, generally designated 28, to beincorporated in the apparatus according to the invention, will now bedescribed with reference to FIGS. 10-27.

The system 28 shown in FIG. 10 comprises an internal energy source inthe form of an implanted energy transforming device 30 adapted to supplyenergy consuming components of the reflux disease treatment apparatuswith energy via a power supply line 32. An external energy transmissiondevice 34 includes a wireless remote control transmitting a wirelesssignal, which is received by a signal receiver which may be incorporatedin the implanted energy transforming device 30, or be separate. Theimplanted energy transforming device 30 transforms energy from thesignal into electric energy which is supplied via the power supply line32.

The system 28 of FIG. 10 is shown in a more generalized block diagramform in FIG. 11, wherein the patient's skin 36, generally shown by avertical line, separates the interior of the patient 29 to the right ofthe line from the exterior to the left of the line.

FIG. 11 shows a simplified block diagram showing the movementrestriction device 10, the energy transforming device 30 powering thedevice 10 via power supply line 32, and the external energy transmissiondevice 34.

FIG. 12 shows an embodiment of the invention identical to that of FIG.11, except that a reversing device in the form of an electric switch 38operable by polarized energy also is implanted in the patient 29 forreversing the device 10. The wireless remote control of the externalenergy transmission device 34 transmits a wireless signal that carriespolarized energy and the implanted energy transforming device 30transforms the wireless polarized energy into a polarized current foroperating the electric switch 38. When the polarity of the current isshifted by the implanted energy transforming device 30 the electricswitch 38 reverses the function performed by the device 10.

FIG. 13 shows an embodiment of the invention identical to that of FIG.11, except that an operation device 40 implanted in the patient forregulating the reflux disease treatment device 10 is provided betweenthe implanted energy transforming device 30 and the device 10. Thisoperation device can be in the form of a motor 40, such as an electricservomotor. The motor 40 is powered with energy from the implantedenergy transforming device 30, as the remote control of the externalenergy transmission device 34 transmits a wireless signal to thereceiver of the implanted energy transforming device 30.

FIG. 14 shows an embodiment of the invention identical to that of FIG.11, except that it also comprises an operation device is in the form ofan assembly 42 including a motor/pump unit 78 and a fluid reservoir 46is implanted in the patient. In this case the device 10 is hydraulicallyoperated, i.e. hydraulic fluid is pumped by the motor/pump unit 44 fromthe fluid reservoir 46 through a conduit 48 to the device 10 to operatethe device, and hydraulic fluid is pumped by the motor/pump unit 44 backfrom the device 10 to the fluid reservoir 46 to return the device 10 toa starting position. The implanted energy transforming device 30transforms wireless energy into a current, for example a polarizedcurrent, for powering the motor/pump unit 44 via an electric powersupply line 50.

Instead of a hydraulically operated movement restriction device 10, itis also envisaged that the operation device comprises a pneumaticoperation device. In this case, pressurized air can be used forregulation and the fluid reservoir is replaced by an air chamber and thefluid is replaced by air.

In all of these embodiments the energy transforming device 30 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the apparatus.

The external energy transmission device 34 is preferably wireless andmay include a remotely controlled control device for controlling thedevice 10 from outside the human body.

Such a control device may include a wireless remote control as well as amanual control of any implanted part to make contact with by thepatient's hand most likely indirect for example a button to press placedunder the skin.

FIG. 15 shows an embodiment of the invention comprising the externalenergy transmission device 34 with its wireless remote control, thedevice 10, in this case hydraulically operated, and the implanted energytransforming device 30, and further comprising a hydraulic fluidreservoir 52, a motor/pump unit 44 and an reversing device in the formof a hydraulic valve shifting device 54, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy transmission or included in the same. The motor of the motor/pumpunit 44 is an electric motor. In response to a control signal from thewireless remote control of the external energy transmission device 34,the implanted energy transforming device 30 powers the motor/pump unit44 with energy from the energy carried by the control signal, wherebythe motor/pump unit 44 distributes hydraulic fluid between the hydraulicfluid reservoir 52 and the device 10. The remote control of the externalenergy transmission device 34 controls the hydraulic valve shiftingdevice 54 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 44 fromthe hydraulic fluid reservoir 52 to the device 10 to operate the device10, and another opposite direction in which the fluid is pumped by themotor/pump unit 44 back from the device 10 to the hydraulic fluidreservoir 52 to return the device 10 to a starting position.

FIG. 16 shows an embodiment of the invention identical to that of FIG.15, except that an internal control unit 56 controlled by the wirelessremote control of the external energy transmission device 34, anaccumulator 58 and a capacitor 60 also are implanted in the patient. Theinternal control unit 56 arranges storage of electric energy receivedfrom the implanted energy transforming device 30 in the accumulator 58,which supplies energy to the device 10. In response to a control signalfrom the wireless remote control of the external energy transmissiondevice 34, the internal control unit 56 either releases electric energyfrom the accumulator 58 and transforms the released energy via powerlines 62 and 64, or directly transforms electric energy from theimplanted energy transforming device 30 via a power line 66, thecapacitor 60, which stabilizes the electric current, a power line 68 andthe power line 64, for the operation of the device 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the device 10 to stretch the stomach according toa pre-programmed time-schedule or to input from any sensor sensing anypossible physical parameter of the patient or any functional parameterof the device.

In accordance with an alternative, the capacitor 60 in the embodiment ofFIG. 16 may be omitted. In accordance with another alternative, theaccumulator 58 in this embodiment may be omitted.

FIG. 17 shows an embodiment of the invention identical to that of FIG.10, except that a battery 70 for supplying energy for the operation ofthe device 10 and an electric switch 72 for switching the operation ofthe device 10 also are implanted in the patient. The electric switch 72is operated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the battery 70 is not inuse, to an on mode, in which the battery 70 supplies energy for theoperation of the device 10.

FIG. 18 shows an embodiment of the invention identical to that of FIG.16, except that an internal control unit 56 controllable by the wirelessremote control of the external energy transmission device 34 also isimplanted in the patient. In this case, the electric switch 72 isoperated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 56 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 56 to releaseelectric energy from the battery 70 for the operation of the device 10.

FIG. 19 shows an embodiment of the invention identical to that of FIG.17, except that an accumulator 58 is substituted for the battery 70 andthe implanted components are interconnected differently. In this case,the accumulator 58 stores energy from the implanted energy transformingdevice 30. In response to a control signal from the wireless remotecontrol of the external energy transmission device 34, the internalcontrol unit 56 controls the electric switch 72 to switch from an offmode, in which the accumulator 58 is not in use, to an on mode, in whichthe accumulator 58 supplies energy for the operation of the device 10.

FIG. 20 shows an embodiment of the invention identical to that of FIG.18, except that a battery 70 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 controls theaccumulator 58 to deliver energy for operating the electric switch 72 toswitch from an off mode, in which the battery 70 is not in use, to an onmode, in which the battery 70 supplies electric energy for the operationof the device 10.

Alternatively, the electric switch 72 may be operated by energy suppliedby the accumulator 58 to switch from an off mode, in which the wirelessremote control is prevented from controlling the battery 70 to supplyelectric energy and is not in use, to a standby mode, in which thewireless remote control is permitted to control the battery 70 to supplyelectric energy for the operation of the device 10.

It should be understood that the switch should be interpreted in itsbroadest embodiment. This means an FPGA or a DA converter or any otherelectronic component or circuit may switch power on and off preferablybeing controlled from outside the patient's body or by an internalcontrol unit.

FIG. 21 shows an embodiment of the invention identical to that of FIG.17, except that a motor 40, a mechanical reversing device in the form ofa gear box 74, and an internal control unit 56 for controlling the gearbox 74 also are implanted in the patient. The internal control unit 56controls the gear box 74 to reverse the function performed by the device10 (mechanically operated). Even simpler is to switch the direction ofthe motor electronically.

FIG. 22 shows an embodiment of the invention identical to that of FIG.20 except that the implanted components are interconnected differently.Thus, in this case, the internal control unit 56 is powered by thebattery 70 when the accumulator 58, suitably a capacitor, activates theelectric switch 72 to switch to an on mode. When the electric switch 72is in its on mode the internal control unit 56 is permitted to controlthe battery 70 to supply, or not supply, energy for the operation of thedevice 10.

FIG. 23 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the device 10, the internal control unit 56, motoror pump unit 44, and the external energy transmission device 34including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 56, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably in the form of a sensor 76, may beimplanted in the patient for sensing a physical parameter of thepatient, such as a contraction wave in the oesophagus informing thepatient is eating. The internal control unit 56, or alternatively theexternal wireless remote control of the external energy transmissiondevice 34, may control the device 10 in response to signals from thesensor 76. A transceiver may be combined with the sensor 76 for sendinginformation on the sensed physical parameter to the external wirelessremote control. The wireless remote control may comprise a signaltransmitter or transceiver and the internal control unit 56 may comprisea signal receiver or transceiver. Alternatively, the wireless remotecontrol may comprise a signal receiver or transceiver and the internalcontrol unit 56 may comprise a signal transmitter or transceiver. Theabove transceivers, transmitters and receivers may be used for sendinginformation or data related to the device 10 from inside the patient'sbody to the outside thereof.

Alternatively, the sensor 76 may be arranged to sense a functionalparameter of the device 10.

Where the motor/pump unit 44 and battery 70 for powering the motor/pumpunit 44 are implanted, the battery 70 may be equipped with a transceiverfor sending information on the condition of the battery 70. To be moreprecise, when charging a battery or accumulator with energy feed backinformation related to said charging process is sent and the energysupply is changed accordingly.

FIG. 24 shows an alternative embodiment wherein the device 10 isregulated from outside the patient's body. The system 28 comprises amovement restriction device 10 connected to a battery 70 via asubcutaneous switch 80. Thus, the regulation of the device 10 isperformed non-invasively by manually pressing the subcutaneous switch,whereby the operation of the device 10 is switched on and off. It willbe appreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.

FIG. 25 shows an alternative embodiment, wherein the system 28 comprisesa movement restriction device 10 in fluid connection with a hydraulicfluid reservoir 52. Non-invasive regulation is performed by manuallypressing the hydraulic reservoir connected to the device 10.

A further embodiment of a system to be incorporated in the apparatusaccording to the invention comprises a feedback device for sendinginformation from inside the patient's body to the outside thereof togive feedback information related to at least one functional parameterof the movement restriction device or apparatus or a physical parameterof the patient, thereby optimizing the performance of the apparatus.

One preferred functional parameter of the device is correlated to thetransfer of energy for charging the internal energy source.

In FIG. 26, an arrangement is schematically illustrated for supplying anaccurate amount of energy to a system 28 implanted in a patient, whoseskin 36 is indicated by a vertical line. A movement restriction device10 is connected to an implanted energy transforming device 30, likewiselocated inside the patient, preferably just beneath the patient's skin36. Generally speaking, the implanted energy transforming device 30 maybe placed in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy transforming device 30 is adapted to receive wireless energy Etransmitted from an external energy source 34 a provided in the externalenergy transmission device 34 located outside the patient's skin 36 inthe vicinity of the implanted energy transforming device 30.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 34 a and an adjacent secondary coil arranged inthe implanted energy transforming device 30. When an electric current isfed through the primary coil, energy in the form of a voltage is inducedin the secondary coil which can be used to operate a movementrestriction device, e.g. after storing the incoming energy in an energystoring device or accumulator, such as a battery or a capacitor.However, the present invention is generally not limited to anyparticular energy transfer technique, TET devices or energy storingdevices, and any kind of wireless energy may be used.

The amount of energy received inside the body to the device may becompared with the energy used by the device. The term used by the deviceis then understood to include also energy stored by the device. Theamount of transferred energy can be regulated by means of an externalcontrol unit 34 b controlling the external energy source 34 a based onthe determined energy balance, as described above. In order to transferthe correct amount of energy, the energy balance and the required amountof energy can be determined by means of an internal control unit 56connected to the reflux disease treatment device 10. The internalcontrol unit 56 may thus be arranged to receive various measurementsobtained by suitable sensors or the like, not shown, measuring certaincharacteristics of the r10, somehow reflecting the required amount ofenergy needed for proper operation of the device 10. Moreover, thecurrent condition of the patient may also be detected by means ofsuitable measuring devices or sensors, in order to provide parametersreflecting the patient's condition. Hence, such characteristics and/orparameters may be related to the current state of the device 10, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by, e.g., body temperature, bloodpressure, heartbeats and breathing.

Furthermore, an energy storing device or accumulator 58 may optionallybe connected to the implanted energy transforming device 30 foraccumulating received energy for later use by the device 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a battery, and the measuredcharacteristics may be related to the current state of the battery, suchas voltage, temperature, etc. In order to provide sufficient voltage andcurrent to the device 10, and also to avoid excessive heating, it isclearly understood that the battery should be charged optimally byreceiving a correct amount of energy from the implanted energytransforming device 30, i.e., not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 56. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 56 is adapted to determine the energybalance and/or the currently required amount of energy, (either energyper time unit or accumulated energy) based on measurements made by theabove-mentioned sensors or measuring devices on the reflux diseasetreatment device 10, or the patient, or an energy storing device ifused, or any combination thereof. The internal control unit 56 isfurther connected to an internal signal transmitter 82, arranged totransmit a control signal reflecting the determined required amount ofenergy, to an external signal receiver 34 c connected to the externalcontrol unit 34 b. The amount of energy transmitted from the externalenergy source 34 a may then be regulated in response to the receivedcontrol signal.

Alternatively, sensor measurements can be transmitted directly to theexternal control unit 34 b wherein the energy balance and/or thecurrently required amount of energy can be determined by the externalcontrol unit 34 b, thus integrating the above-described function of theinternal control unit 56 in the external control unit 34 b. In thatcase, the internal control unit 56 can be omitted and the sensormeasurements are supplied directly to the internal signal transmitter 82which sends the measurements over to the external signal receiver 34 cand the external control unit 34 b. The energy balance and the currentlyrequired amount of energy can then be determined by the external controlunit 34 b based on those sensor measurements.

Hence, the present solution employs the feed back of informationindicating the required energy, which is more efficient than previoussolutions because it is based on the actual use of energy that iscompared to the received energy, e.g. with respect to the amount ofenergy, the energy difference, or the energy receiving rate as comparedto the energy rate used by the device 10. The device 10 may use thereceived energy either for consuming or for storing the energy in anenergy storage device or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the device.

The internal signal transmitter 82 and the external signal receiver 34 cmay be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 82 and the externalsignal receiver 34 c may be integrated in the implanted energytransforming device 30 and the external energy source 34 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

To conclude, the energy supply arrangement illustrated in FIG. 26 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 56. A control signal reflectingthe required amount of energy is also created by the internal controlunit 56, and the control signal is transmitted from the internal signaltransmitter 82 to the external signal receiver 34 c. Alternatively, theenergy balance can be determined by the external control unit 34 binstead depending on the implementation, as mentioned above. In thatcase, the control signal may carry measurement results from varioussensors. The amount of energy emitted from the external energy source 34a can then be regulated by the external control unit 34 b, based on thedetermined energy balance, e.g. in response to the received controlsignal. This process may be repeated intermittently at certain intervalsduring ongoing energy transfer, or may be executed on a more or lesscontinuous basis during the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 34 a, suchas voltage, current, amplitude, wave frequency and pulsecharacteristics.

A method is thus provided for controlling transmission of wirelessenergy supplied to an electrically operable reflux disease treatmentdevice implanted in a patient. The wireless energy E is transmitted froman external energy source located outside the patient and is received byan internal energy receiver located inside the patient, the internalenergy receiver being connected to the device 10 for directly orindirectly supplying received energy thereto. An energy balance isdetermined between the energy received by the internal energy receiverand the energy used for the device 10. The transmission of wirelessenergy E from the external energy source is then controlled based on thedetermined energy balance.

A system is also provided for controlling transmission of wirelessenergy supplied to an electrically operable movement restriction device10 implanted in a patient. The system is adapted to transmit thewireless energy E from an external energy source located outside thepatient which is received by an implanted energy transforming devicelocated inside the patient, the implanted energy transforming devicebeing connected to the device 10 for directly or indirectly supplyingreceived energy thereto. The system is further adapted to determine anenergy balance between the energy received by the implanted energytransforming device and the energy used for the device 10, and controlthe transmission of wireless energy E from the external energy source,based on the determined energy balance.

The functional parameter of the device is correlated to the transfer ofenergy for charging the internal energy source.

In yet an alternative embodiment, the external source of energy iscontrolled from outside the patient's body to release electromagneticwireless energy, and released electromagnetic wireless energy is usedfor operating the device 10.

In another embodiment, the external source of energy is controlling fromoutside the patient's body to release non-magnetic wireless energy, andreleased non-magnetic wireless energy is used for operating the device10.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 14-26 could be combined in many different ways. Forexample, the electric switch 38 operated polarized energy could beincorporated in any of the embodiments of FIGS. 12, 15-21, the hydraulicvalve shifting device 54 could be incorporated in the embodiment of FIG.24, and the gear box 74 could be incorporated in the embodiment of FIG.33. It should be noted that the switch simply could mean any electroniccircuit or component.

Wireless transfer of energy for operating the movement restrictiondevice 10 has been described to enable non-invasive operation. It willbe appreciated that the device 10 can be operated with wire bound energyas well. One such example is shown in FIG. 26, wherein an externalswitch 84 is interconnected between the external energy source 34 a andan operation device, such as an electric motor regulating the device 10,by means of power lines 86 and 88. An external control unit 34 bcontrols the operation of the external switch to effect proper operationof the device 10.

Hydraulic or Pneumatic Powering

FIGS. 28-31 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering a movement restriction deviceaccording to the invention.

FIG. 28 shows a system for treating reflux disease as described abovewith. The system comprises a device 10 and further a separate regulationreservoir 46, a one way pump 44 and an alternate valve 54.

FIG. 29 shows the device 10 and a fluid reservoir 46. By moving the wallof the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the device may be performedwithout any valve, just free passage of fluid any rime by moving thereservoir wall.

FIG. 30 shows the device 10, a two way pump 44 and the regulationreservoir 46.

FIG. 31 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 46 and a servo reservoir 90. The servoreservoir 90 mechanically controls a movement restriction device 10 viaa mechanical interconnection 94. The device 10 has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 92 in fluid connection with the device 10. Alternatively, thecavity contains compressible gas, which can be compressed and expandedunder the control of the servo reservoir 90.

The servo reservoir 90 can also be part of the device itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This reflux disease treatment system isillustrated in FIG. 32-c. In FIG. 31, a flexible subcutaneous regulationreservoir 46 is shown connected to a bulge shaped servo reservoir 90 bymeans of a conduit 48. This bellow shaped servo reservoir 90 iscomprised in a flexible movement restriction device 10. In the stateshown in FIG. 32, the servo reservoir 90 contains a minimum of fluid andmost fluid is found in the regulation reservoir 46. Due to themechanical interconnection between the servo reservoir 90 and the device10, the outer shape of the device 10 is contracted, i.e., it occupiesless than its maximum volume. This maximum volume is shown with dashedlines in the figure.

FIG. 32 shows a state wherein a user, such as the patient in with thedevice is implanted, presses the regulation reservoir 46 so that fluidcontained therein is brought to flow through the conduit 48 and into theservo reservoir 90, which, thanks to its bellow shape, expandslongitudinally. This expansion in turn expands the device 10 so that itoccupies its maximum volume, thereby stretching the stomach wall (notshown), which it contacts.

The regulation reservoir 46 is preferably provided with means 46 a forkeeping its shape after compression. This means, which is schematicallyshown in the figure, will thus keep the device 10 in a stretchedposition also when the user releases the regulation reservoir. In thisway, the regulation reservoir essentially operates as an on/off switchfor the reflux disease treatment system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 33 and 34. The block diagram shownin FIG. 33 comprises with a first closed system controlling a secondclosed system. The first system comprises a regulation reservoir 46 anda servo reservoir 90. The servo reservoir 90 mechanically controls alarger adjustable reservoir 92 via a mechanical interconnection 94. Amovement restriction device 10 having an expandable/contactable cavityis in turn controlled by the larger adjustable reservoir 92 by supply ofhydraulic fluid from the larger adjustable reservoir 92 in fluidconnection with the device 10.

An example of this embodiment will now be described with reference toFIG. 34. Like in the previous embodiment, the regulation reservoir isplaced subcutaneous under the patient's skin and is operated by pushingthe outer surface thereof by means of a finger. The regulation reservoir46 is in fluid connection with a bellow shaped servo reservoir 90 bymeans of a conduit 48. In the first closed system 46, 48, 90 shown inFIG. 32a , the servo reservoir 90 contains a minimum of fluid and mostfluid is found in the regulation reservoir 46.

The servo reservoir 90 is mechanically connected to a larger adjustablereservoir 92, in this example also having a bellow shape but with alarger diameter than the servo reservoir 90. The larger adjustablereservoir 92 is in fluid connection with the device 10. This means thatwhen a user pushes the regulation reservoir 46, thereby displacing fluidfrom the regulation reservoir 46 to the servo reservoir 90, theexpansion of the servo reservoir 90 will displace a larger volume offluid from the larger adjustable reservoir 92 to the device 10. In otherwords, in this reversed servo, a small volume in the regulationreservoir is compressed with a higher force and this creates a movementof a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.32a-c , the regulation reservoir 46 is preferably provided with means 46a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the device 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the reflux disease treatment system.

In FIG. 35, a flow chart illustrating steps performed when implanting adevice in accordance with the present invention. First in a step 102, anopening is cut in the abdominal wall. Next, in a step 104 an area aroundthe stomach is dissected. Thereupon, in a step 106 at least one movementrestriction device in accordance with the invention is placed in contactwith the stomach wall, in particular the fundus wall. The stomach wallis then sutured in a step 108.

Method for the Restoration of the Location of the Cardia and the Fundus

FIG. 36 shows how an instrument 200 having at least one flexible part201 is introduced into the esophagus 24 of a patient that is sufferingfrom a hiatal hernia 202 where a part of the esophagus 24 and fundus 16that is supposed to be located below the diaphragm 18 has moved throughthe hiatus opening 18 a to a position above the diaphragm 18.

In FIG. 37 it is shown how, in a subsequent step, a member 203 having alarger cross sectional area than said instrument 200 is released fromthe instrument 200. The member 203 is adapted as to have across-sectional that is larger than the opening of the cardia 14. Thiscan be achieved by radial expansion of the member 203. The instrument200 is then pushed in a proximal direction so that the cardia 14 and thefundus 16, or part of fundus 16, incorrectly located above diaphragm 18,slide through the hiatus opening 18 a back to a correct position belowthe diaphragm 18.

FIG. 38 shows an alternative method to the one shown in FIG. 37 which isan embodiment of the invention. In many aspects, this figure is similarto FIG. 37. In FIG. 38, the instrument 200 is adapted to release aballoon member 204 at the proximal end 205 of the instrument 200 in thelower part of the stomach 206, and using the balloon member 204 to pushthe instrument 200 against the lower wall part of the stomach 207 sothat the cardia 14 and the fundus 16 or part of fundus 16 slide throughthe hiatus opening 18 a to a position below the diaphragm 18.

FIG. 39 shows yet an alternative method which is an embodiment of theinvention. Again, this figure is in many aspects similar to FIG. 37.However, in FIG. 39 the method involves attaching the member 203 to thewall of the stomach 207 by a fixation 208. As described above theinstrument is then pushed in a proximal direction so the cardia 14 andthe fundus 16 or, part of fundus 16, slides below the diaphragm 18.

FIG. 40 shows how the fundus 16 and cardia 14 is located in a positionbelow the diaphragm 18 after having been pushed through the hiatalopening 18 a by the instrument 200.

FIG. 41 shows a subsequent step of the method. After the fundus 16 andcardia 14 has been pushed into its correct position below the diaphragm18, the wall of the fundus 16 a is affixed to the lower part of theoesophagus 24. This is carried out by using a member 209 in the proximalpart 205 of the instrument 200 which is capable of providing sutures orstaples 210. The fixation hinders the movement of the cardia 14 and thefundus 16 to a position above the diaphragm 18.

Other methods according to the invention are briefly described below.

A method of treating reflux disease of a patient comprises the step ofimplanting a reflux disease treatment system according to the inventioninto the patient's body.

A method of using the system for treating reflux disease according tothe invention comprises the step of regulating the devicepostoperatively to prevent reflux.

A method for surgically placing a movement restriction device accordingto the invention in a patient comprises the steps of cutting an openingin the abdominal wall of the patient, dissecting the area around thestomach, placing a movement restriction device attached to the stomachwall, and suturing the stomach wall.

A method of using a reflux disease treatment system, postoperativelycontrolled from outside the body, regulating the device, comprises thesteps of filling out a volume attached to a part of the stomach wall,and regulating the device from outside the patient's body to affect thereflux of the patient.

A method of using a movement restriction device comprises the steps offilling out a volume in a first part of the stomach wall by placing afirst part of the device, filling out a volume in a second part of thestomach wall by placing a second part of the device, and regulating thedevices from outside the patient's body to affect the reflux of thepatient.

A method of treating reflux disease in a patient comprises the steps ofinserting a needle or a tube like instrument into the abdomen of thepatient's body, using the needle or tube like instrument to fill thepatient's abdomen with gas thereby expanding the abdominal cavity,placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars into thepatient's abdomen, inserting at least one dissecting tool through one ofsaid at least two laparoscopic trocars and dissecting an intendedplacement area of at least one portion of the stomach of the patient,placing a movement restriction device according to the invention on thestomach fundus wall, invaginating the device in the stomach fundus wall,suturing the stomach wall to itself to keep the device in place,suturing the fundus of the stomach towards the lower part of theoesophagus, and preventing the cardia to slide up through the diaphragminto the thorax. Using the method and device as described herein willprovide a treatment of Gastroesophageal Reflux Disease which is veryeffective and which does not suffer from complications such as damagingof tissue and undesired migration of non tissue into tissue.

The filling body of the device can be adapted to be pushed or pulledthrough a trocar for laparoscopic use, where the trocar has a diameterthat is smaller than the relaxed diameter of the body. The filling bodycan include an outer wall and a hollow gas filled inner part that allowthe body to pass through the trocar. Alternatively, the filling body caninclude an outer wall and a hollow fluid filled inner part that allowthe body to pass through the trocar. In this latter case, the fluid canbe a gel. The filling body can further include multiple parts that canbe inserted into the trocar, and that can then be put together into oneunitary piece inside the patient's body, allowing the filling body topass through the trocar. The filling body can include an outer wall anda hollow compressed inner part that is filled with a fluid or gel afterinsertion into the patient's body. The can further include an injectionport that can be used to fill the filling body with a fluid afterinsertion into the patient's body through the injection port.

The filling body of the device can be an elastic compressible material,allowing the filling body to pass through the trocar. The filling bodycan be made from a material that is softer than 25 shure, or even 15shure.

The filling body can also include an outer wall substantially taking theshape of a ball. The filling body can also include at least one holdingdevice adapted to be used for pushing or pulling the filling bodythrough a trocar for laparoscopic use. The holding device can be adaptedto hold a prolongation of the device that is adapted to be held by asurgical instrument. The holding device can also hold a tread or bandinserted through the holding device. The holding device can also be atleast partly placed inside the outer wall of the filling body. Thefilling body of the device can preferably has a size that is larger thanthe intestinal outlet from the stomach, to avoid ileus if the ball, as acomplication, should enter into the stomach. Preferably, the body has asmallest outer diameter between 30 mm and 40 mm or larger. Preferably,the body has a smallest outer circumference between 30 mm and 150 mm.

Preferred embodiments of a device for treating reflux disease, a systemcomprising a device for treating reflux disease, and a method accordingto the invention have been described. A person skilled in the artrealizes that these could be varied within the scope of the appendedclaims. Thus, although the different features have been described inspecific embodiments, it will be appreciated that they can be combinedin different configurations when applicable. For example, althoughhydraulic control has been described in association with the deviceconfiguration of FIG. 4 A-B, it can also be applied to the deviceconfigurations of FIGS. 2 A-B and 3A-B.

It is important that the implanted reflux treatment device is firmlykept in place in the stomach wall in which it is invaginated. To thisend, the reflux treatment device can be provided with one or morethrough holes adapted for receiving sutures or staples used for fixationof the invagination. Such an embodiment is shown in FIG. 42, where thereflux treatment device 10 is provided with a row of holes 10 i providedon a protruding flange-like protrusion on the reflux treatment device.In this embodiment, the row of holes extend along the longitudinal axisof the reflux treatment device.

FIG. 43 illustrates how sutures 314 are provided so that they runthrough the stomach wall 12 a and through the holes 10 i. In this way,the reflux treatment device is fixed in place in the pouch created fromthe stomach wall and will thus be prevented from sliding.

Although a plurality of holes is illustrated in the FIG. 42, it will beappreciated that one single hole is sufficient to obtain improvedfixation of the reflux treatment device 10.

FIG. 44 illustrates a reflux treatment device provided with an inletport 10 h. The reflux treatment device is invaginated in the stomachwall and the inlet port 10 h is available for connection to a tube orthe like from the abdominal area of the patient.

FIG. 45 illustrates an invaginated reflux treatment device wherein,instead of an inlet port, a fixed tube 10 g extends into the abdominalarea of the patient.

FIG. 46 is a figure similar to FIG. 44 but also illustrating tunnelingof a connection tube 10 g in the stomach wall between the inlet port 10h and the reflux treatment device 10.

It has been shown that the shape of the reflux treatment device can takemany different forms. It will be appreciated that also the material ofthe reflux treatment device can vary. It is preferred that the refluxtreatment device is provided with a coating, such as a Parylene,polytetrafluoroethylene (PTFE), or polyurethane coating, or acombination of such coatings, i.e., a multi-layer coating. This coatingor multi-layer coating improves the properties of the reflux treatmentdevice, such as its resistance to wear.

In one embodiment, the reflux treatment device comprises an inflatabledevice expandable to an expanded state. In this case, the inflatabledevice is provided with an inlet port for a fluid and is adapted to beconnected to a gastroscopic instrument. This embodiment will now bedescribed in detail with reference to FIGS. 47a -47 d.

An inflatable reflux treatment device in its non-expanded state is shownin FIG. 47a . It is essentially a balloon-like, deflated device 10having an inlet port 10 h. In this state, the inflatable device has adiameter of a few millimeters at the most, allowing it to be insertedinto the stomach through the esophagus of the patient by means of agastroscopic, tube-like instrument 600, depicted in FIG. 47b . Theinstrument comprises an outer sleeve 600 a and an inner sleeve 600 bwhich can be displaced longitudinally relatively to the outer sleeve.The inner sleeve is provided with a cutter in the form of a cutting edge615 at the distal end thereof. This cutting edge can be used for cuttinga hole in the stomach wall, as will be explained in detail in thefollowing.

When the instrument reaches a stomach wall, see FIG. 47c , the innersleeve is brought forward from its position in the outer sleeve and intocontact with the stomach wall 12 a. The cutting edge 615 of the innersleeve then cuts a hole in the stomach wall so as to allow subsequentinsertion of the reflux treatment device 10 into and through this hole,see FIG. 47d . In order to push the reflux treatment device through thehole, a piston 602 may be provided in the instrument. Thus, theinstrument further comprises a piston 602 adapted for pushing a deflatedreflux treatment device 10 out from a position in the inner sleeve, thisposition being shown in FIG. 47b , to a position outside of the innersleeve, this being shown in FIG. 47 d.

In order to protect the deflated reflux treatment device 10 from thecutting edge 615 of the inner sleeve, a further protective sleeve (notshown) can be provided around the reflux treatment device.

An intraluminar method of invaginating a reflux treatment device 10 onthe outside of the stomach wall 12 a will now be described withreference to FIGS. 48a-i . Initially, an instrument 600, preferably agastroscopic instrument, is inserted into the mouth of the patient, seeFIG. 48a . The instrument comprises an injection device 601, 602 forinjecting either fluid or a device into the stomach of the patient. Theinstrument 600 further comprises a control unit 606 adapted forcontrolling the operation of the instrument. To this end, the controlunit 606 comprises one or more steering devices, in the embodiment shownin the figure in the form of two joysticks 603 and two control buttons604. A display 605 is provided for displaying the image provided by acamera (not shown) arranged at the outer end of the elongated member607, see FIGS. 48e-i . The camera may be assisted by a light source (notshown).

The instrument is further inserted into the esophagus and into thestomach of the patient, see FIG. 48b . By means of the instrument 600, ahole 12 b is created in the wall of the stomach 12. To this end, theinstrument is provided with one or more cutters 615 at the distal endthereof, for example in the way described above with reference to FIGS.47a-d . These cutters can of course be designed in different ways, suchas a toothed drum cutter rotating about the center axis of the tube-likeinstrument. The instrument 600 is hollow providing a space for thereflux treatment device 10 in its deflated state.

After cutting a hole in the stomach wall, the distal end of theinstrument 600 is inserted into and through the hole 12 b so that itends up outside the stomach wall 12 a. This is shown in FIG. 48c ,showing a side view of the stomach 12, and FIG. 48d , which is asectional view through the stomach of FIG. 48c taken along the linesVd-Vd. The deflated reflux treatment device 10 is then inserted in theabdominal area.

The instrument 600 is adapted to create a “pocket” or “pouch” on theoutside of the stomach 12 around the hole 12 b in the stomach wall. Suchan instrument and the method of providing the pouch will now bedescribed.

FIGS. 48e-i show a gastroscopic or laparoscopic instrument forinvaginating a reflux treatment device 10 in the stomach wall 12 a ofthe patient by creating a pouch of stomach wall 12 a material in whichthe reflux treatment device is placed. The instrument, generallydesignated 600, and which may comprise the features described above withreference to FIGS. 47a-d , comprises an elongated member 607 having aproximal end and a distal end, the elongated member 607 having adiameter less than that of the patient's esophagus and being flexiblesuch as to allow introduction of the flexible elongated member 607 withits distal end first through the patient's throat, esophagus and intothe stomach 12 to the stomach wall 12 a.

The stomach penetration device or cutter 615 is provided on theelongated member 607 at the distal en thereof for penetrating thestomach wall 12 a so as to create a hole in the stomach wall 12 a, toallow introduction of the elongated member 607 through the hole. Thestomach penetration device 615 could be adapted to be operable forretracting said stomach penetration device 615 after the stomach funduswall 12 a has been penetrated, for not further damaging tissue withinthe body. The instrument further comprises a special holding device 609provided on the elongated member 607 on the proximal side to thepenetration device 615.

The elongated member further comprises an expandable member 611 which isadapted to be expanded after the elongated member has penetrated thestomach wall 12 a and thereby assist in the creation of a cavity orpouch adapted to hold the reflux treatment device 610. The expandablemember 611 may comprise an inflatable circular balloon providedcircumferentially around the distal end portion of the flexibleelongated member 607.

The method steps when invaginating the reflux treatment device will nowbe described in detail. After the instrument 600 has been inserted intothe stomach 12, the stomach penetration device 615 is placed intocontact with the stomach wall 12 a, see FIG. 48e . The stomachpenetration device or cutter 615 is then brought to create the hole 12 bin the stomach wall, whereafter at least the expandable member 611 isbrought through the hole 12 b in the stomach wall. The special holdingdevice 609 is in this step brought to a holding state wherein it expandsradially so as to form an essentially circular abutment surface to thestomach wall 12 a, see FIG. 48f . In this way, the insertion of thestomach penetration device 615 and the expandable member 611 through thehole 12 a in the stomach wall is limited to the position shown in FIG.48 f.

The expandable member 611 is then expanded. In the case the expandablemember comprises a balloon or the like, air or other fluid is injectedinto it.

The part of the elongated member 607 comprising the expandable member611 is then retracted in the proximal direction, as indicated by thearrow in FIG. 48g , thereby pulling the stomach wall 612 into a basketlike structure created by the special holding device 609.

A suturing or stapling device 608 is further provided, either as adevice connected to the elongated member 607 or as a separateinstrument. The suturing or stapling member comprises a suturing orstapling end 613 which is adapted to close the cavity or pouch by meansof stomach to stomach sutures or staples 14.

In a further step, illustrated in FIG. 48h , an inflatable refluxtreatment device 10 is placed in its deflated state in the basket likestructure. The reflux treatment device 10 is then inflated to itsinflated or expanded state, see FIG. 48i . This inflation of the refluxtreatment device 10 can be accomplished by injecting a fluid or a gelinto the deflated reflux treatment device. It can also be accomplishedby injecting a material which is allowed to cure, thereby forming asolid device 10. Thus, the reflux treatment device 10 shown in FIGS. 48hand 48i can illustrate either a balloon-like device which issubsequently filled with fluid or gel or alternatively a material whichis simply injected into the basket like structure formed by the stomachwall 12 a.

The fluid which is used to fill the reflux treatment device 10 could beany suitable fluid suitable to fill the inflatable device 10, such as asalt solution. In another embodiment, when this fluid is a fluid whichis adapted to be transformed into solid state, the fluid could be liquidpolyurethane.

In order to minimize or entirely eliminate leakage, the fluid isiso-tonic, i.e., it has the same osmolarity as human body fluids.Another way of preventing diffusion is to provide a fluid whichcomprises large molecules, such as iodine molecules.

The stomach-to-stomach sutures or staples are preferably provided withfixation portions exhibiting a structure, such as a net like structure,adapted to be in contact with the stomach wall to promote growth in ofhuman tissue to secure the long term placement of the reflux treatmentdevice attached to the stomach wall.

After the inflatable device 10 has been inflated, partly or fully, theinlet port 10 b (not shown in FIGS. 48h and 48i ) of the refluxtreatment device 10, is sealed and the instrument 600 is retracted fromthe hole 12 b, which is subsequently closed in some suitable way, suchas by means of the instrument 600. The instrument is then removed fromthe stomach 600 and the inflatable device 10 in its inflated or expandedstate is invaginated by a stomach wall portion of the patient on theoutside of the stomach wall. During one or more of the above describedsteps, the stomach may be inflated with gas, preferably by means of thegastroscopic instrument.

The reflux treatment device 10 described above with reference to FIGS.48a-i has been described as an inflatable reflux treatment device. Itwill be appreciated that is also can be an elastic reflux treatmentdevice with an elasticity allowing compression so as to be inserted intoa gastroscopic instrument and which expands to an expanded state afterleaving the instrument.

Combination of a Reflux Treatment Device and a Volume Filling Device

The apparatus for treating reflux can have the additional functionalityof treating obesity. In such an embodiment, the reflux treatment devicemay be a volume filling device that fills a volume of the stomach andthereby creating satiety.

An embodiment having this function is shown in FIG. 49, wherein acombined reflux treatment device and obesity treatment device 310 isinvaginated in the stomach wall close to and at least partially abovethe patient's cardia 14 when the patient is in a standing position andis fixed to a position above the cardia area 14 c by a fixation, such assutures or staples 22. For example a direct or indirect fixation to thediaphragm muscle or associated muscles may be provided. As analternative a direct or indirect fixation to the esophagus above andclose to the angle of His can be provided. In this alternativeembodiment, the combined device 310 rests in a position against stomachwall of the fundus when implanted and which also fills a volume abovethe cardia area 14 c between the cardia and the diaphragm muscle so thatthe cardia is prevented from slipping up into the thorax cavity, wherebyreflux disease is prevented.

Such a combined device 310 may be used for keeping electronics and/or anenergy source and/or hydraulic fluid. Hydraulic fluid from that devicemay be distributed to several smaller inflatable device areas to varythe stretching area from time to time avoiding any possible morepermanent stretching effect of the stomach wall. Even mechanicallyseveral stretching areas may be used.

In an alternative embodiment, which is shown in FIG. 50, the volume ofan inflatable reflux treatment device 310 may be in fluid connectionwith one or more preferably smaller inflatable devices or chambers 10 b.These chambers are adapted to communicate with fluid or air being movedbetween the chambers.

Thus, the large chamber 310 is adapted to, with its main volume to be areflux treatment device for reducing the size of the food cavity and fortreating reflux disease and the one or several small chambers areadapted to function as the inflatable devices to treat obesity, whereinthe main chamber is adapted to communicate with fluid or air to thesmall chambers causing a stretching effect in the stomach wall therebyfurther treating obesity.

FIG. 51 show an embodiment with a combination of a volume filling deviceinvaginated in the central or lower portion of the stomach and astretching device invaginated in the upper portion or fundus of thepatient's stomach. These two devices serve to treat obesity.

The volume filling device 399 fills a volume of the stomach creatingsatiety. The stretching device stretches the wall of the stomach. Thisstretches the tissue setting off a endogenous signaling that createssatiety. This mimics the stretching effect of filling the stomach withfood. Thus, in FIG. 51 there is shown an adjustable volume fillingdevice 399, which is invaginated in the stomach wall of a patient'sstomach 312. Additionally, an adjustable stretching device 350 with thepreviously described function is invaginated in the stomach fundus wallof the patient. It is preferred that the volume filling device 399 issubstantially larger than the stretching device 350.

The volume filling device 399 and the stretching device 350 can beadapted to treat reflux. In one embodiment, the volume filling deviceand the stretching device are positioned to prevent the cardia 14 fromslipping upwards trough the opening of the hernia 18 a to a positionabove the diaphragm 18.

The volume filling device 399 and the stretching device 350 are in fluidcommunication with each other via a first fluid tube 352, in which apump 354 is provided. The pump 354 is under the control from an energytransforming device 330, which is adapted to supply the pump 350 withenergy via a power supply line 356. The energy transforming device 330is also connected to a sensor 319 provided in the esophagus of thepatient so that food intake can be detected.

The reflux treatment device 10 and the stretching device 350 are also influid communication with each other via a second fluid tube 358, whichpreferably has a smaller cross-sectional area than the first fluid tube352.

The operation of this arrangement is as follows. The volume fillingdevice 399 functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12.Additionally, when the stretching device 350 is enlarged by pumpingfluid from the volume filling device 10 and to the stretching device 350by means of the pump 354, the stomach fundus wall is stretched, creatinga feeling of satiety for the patient. Thus, for example when food intakeis detected by means of the sensor 319, fluid is automatically pumpedinto the stretching device 350 to increase the feeling of satiety andthereby limit the food intake.

When fluid has been injected into the stretching device 350, theinternal pressure therein is higher than the internal pressure in thereflux treatment device 399. This difference in pressure will create aflow of fluid in the second, preferably narrower tube 358 from thestretching device 350 to the reflux treatment device 399. The flow ratewill be determined by among other things the difference in pressure andthe cross-sectional area of the second tube 358. It is preferred thatthe second tube is so dimensioned, that the pressures in the volumefiling device 399 and the stretching device 350 will return toequilibrium after 3 hours after fluid has been injected into thestretching device 350 to create the feeling of satiety.

In this embodiment, the function of the second tube 358 is to allowfluid to return from the stretching device 350 to the volume fillingdevice 399. It will be appreciated that this function also can beperformed by the pump 354 in the first tube 352 and that the second tube358 then can be omitted.

FIG. 51b illustrates an embodiment similar to the one illustrated inFIG. 51a . Thus, there is provided an adjustable volume filling device310, which is invaginated in the stomach wall of a patient's stomach312. Additionally, an adjustable stretching device 350 with thepreviously described function is invaginated in the stomach fundus wallof the patient. It is preferred that the volume filling device 310 issubstantially larger than the stretching device 350.

The volume filling device 310 and the stretching device 350 are in fluidcommunication with each other via a first fluid tube 352, and a secondfluid tube, which preferably has a smaller cross-sectional area than thefirst tube. However, instead of a pump, there is provided a non-returnvalve 360 in the first fluid tube 352 instead of an energized pump. Thisnon-return valve 360 allows fluid to flow in the direction from thevolume filling device 310 and to the stretching device 10 but not viceverse. This means that this embodiment may be entirely non-energized.Instead, it operates according to the following principles.

When the food cavity of the stomach 312 is essentially empty, there is astate of equilibrium between the internal pressure of the volume fillingdevice 310 and the stretching device 350. In this state, the stretchingdevice is in a non-stretch state, i.e., it does not stretch a part ofthe stomach fundus wall and thus does not create a feeling of satiety.

When the patient starts to eat, food will enter the food cavity of thestomach 312. This will create increased pressure on the stomach wall inwhich the volume filling device 310 is invaginated and the internalpressure therein will increase. Also, the stomach wall muscles willbegin to process the food in the food cavity by contraction, which alsocontributes to an increased internal pressure in the volume fillingdevice 310.

Since the internal pressure in the stretching device 350 will remainessentially unchanged, because it is located in the upper part of thestomach 312 where no food is exerting a pressure on the stomach wall, afluid flow will be created through the first and second fluid tubes 352,358 in the direction from the volume filling device 310 and to thestretching device 350. This in turn will increase the volume of thestretching device 350, which, by stretching the stomach fundus wall,will provide a feeling of satiety to the patient.

A fluid flow from the stretching device 350 to the volume filling device310 through the second tube 358 will return the pressure of thesedevices to equilibrium as described above with reference to FIG. 51a

Similarly, FIG. 51c illustrates an embodiment wherein the stretchingdevice 350 can be actively regulated by manually pressing an adjustmentreservoir which is provided subcutaneously below the patient's skin.Thus, a regulation reservoir 317 for fluids is connected to theinflatable device by means of a conduit 318 in the form of a tube. Thestretching device 350 is thereby adapted to be regulated,non-invasively, by moving liquid or air from the regulation reservoir317 to the chamber formed by the inflatable device. The regulation ofthe stretching device 350 preferably comprises a reversed servo, i.e., asmall volume is actuated for example by the patient's finger and thissmall volume is in connection with a larger volume.

The volume filling device 310 preferably has an essentially round shapeto not damage the stomach wall. An example thereof is shown in FIG. 51-3a, wherein the volume filling device is essentially egg-shaped. Inanother preferred embodiment, the volume filling device is slightlybent, such as the embodiment shown in FIG. 51-3 b. However, since thestomach wall is strong many different shapes, forms, and dimensions maybe used. In one embodiment, the volume filling device has a diameter ofabout 40 millimeters and a length of about 120 millimeters, resulting ina volume that is about half the volume of the patient's stomach.However, it is preferred that the maximum circumference of the volumefilling device is at least 30 millimeters, more preferably at least 50millimeters, and even more preferably at least 80 millimeters.

It is not necessary that the volume filling device is elongated. In theembodiment shown in FIG. 51-3 c, the volume filling device 310 isessentially spherical or ball-shaped. In order to fill out the stomach,two or more such volume filling devices may be combined to achieve thedesired decrease of the food cavity of the patient's stomach.

It has been mentioned that the volume filling device is secured by thestomach-to-stomach sutures or staples. In order to further improve thefixation, the volume filling device may be provided with a waist portionhaving smaller diameter that the maximum diameter of the volume fillingdevice. Such volume filling device having a waist portion 10 a is shownin FIG. 51-3 d.

The volume filling device 10 may consist of at least twointerconnectable portions so that each portion is easier to insert intothe stomach and further through a hole in the stomach wall. Thus, FIG.51-3 e shows a volume filling device comprising two more or lessspherical sub-parts 310 b. 310 c interconnected by a portion with whichpreferably has smaller diameter. The portion with smaller diameter maycomprise an interconnection means with a reversible function allowingsubsequent disconnection of the two interconnected sub-parts 310 b. 310c. Such means may comprise a bayonet socket, a screw connection or thelike, designated 310 d in the figure. Alternatively, the portion withsmaller diameter may comprise a fixed interconnection, such as resilientlocking hooks provided on one of the sub-parts 310 b, 310 c and engagingthe rim of a hole provided in the other one of the sub-parts 310 b, 310c.

The configuration of the volume filling device 10 is not limited to onewaist portion 310 a. Thus, in FIG. 51-3 f a volume filling device withtwo waist portions is shown.

In order to facilitate positioning of the volume filling device, anattachment means in the form of a handle or the like may be provided onthe outer surface of the volume filling device. One example thereof isshown in FIG. 51-3 g, wherein also a detail view of a handle 51-10 e isshown. In a preferred embodiment, the attachment means is provide at anend portion of the volume filling device 310. In order to avoidprotruding portion on the surface of the volume filling device 310, thehandle 310 e is provided flush with the outer surface of the volumefilling device 310 and a recess 310 f is arranged to allow a grippingtool or instrument (not shown in FIG. 51-3 g) to achieve firm grippingaround the handle 310 e.

The volume filling device may comprise a tube for filling or emptyingthe volume filling device of a fluid or gel. By injecting fluid or gelinto the volume filling device 310, the volume filling device isinflated to an inflated state, as will be described below. The size ofthe volume filling device can also be adjusted by moving fluid or geltherefrom to a different reservoir.

A volume filling device 310 adapted for this is shown in FIG. 51-3 h. Atube 310 g is fixedly attached to the volume filling device. This tubecan be attached to a suitable instrument (not shown) or an injectionport, which will be explained in detail below.

Instead of having a fixedly attached tube, the volume filling device 310may comprise an inlet port 10 h adapted for connection of a separatetube (not shown in this figure).

It is important that the implanted volume filling device is firmly keptin place in the stomach wall in which it is invaginated. To this end,the volume filling device can be provided with one or more through holesadapted for receiving sutures or staples used for fixation of theinvagination. Such an embodiment is shown in FIG. 51-3 j, where thevolume filling device 310 is provided with a row of holes 10 i providedon a protruding flange-like protrusion on the volume filling device. Inthis embodiment, the row of holes extend along the longitudinal axis ofthe volume filling device.

Method for placing a reflux treatment device on the inside of thestomach wall

In the following a method and an instrument for placing a refluxtreatment device on the inside of the stomach wall will be described.

The invagination instrument described in FIG. 52a -1 generallydesignated 630, comprises an elongated tube member 632 similar to theelongated member 607 described above with reference to FIGS. 48a-i .Thus, it can be connected to a control unit 606, see FIG. 48a . Theinvagination instrument 630 further comprises a perforated suctionportion 634, which preferably is elongated. The suction portion 634exhibits a plurality of small holes 636, into which air will be suckedby providing suction in the tube member 632. This suction effect will beused to create a “pocket” or “pouch” in a part of a stomach wall,generally designated 12 a.

In other words, when the tip of the suction portion 634 is pressedagainst the stomach wall 12 a, see FIG. 52a , a small recess will beformed therein. When the suction portion 634 is further pressed againstthe stomach wall 12 a, see FIG. 52b , a larger recess will be formed.The part of the stomach wall 12 a that forms the recess will, due to thesuction effect, adhere to the suction portion 634 of the invaginationinstrument 630. As the suction portion 634 is further pressed into thestomach wall 12 a, see FIG. 52c , a deeper recess will be formed untilthe entire suction portion 634 is embedded in the recess, see FIG. 18 d.

The rim of the recess will at this stage be fixated by means of fixationelements 638 and the suction portion be removed from the instrument, seeFIG. 52e . A compressed elastic reflux treatment device 10 willsubsequently be inserted into the recess, see FIG. 52f , for example inthe way described above with reference to FIG. 47d . This compressedreflux treatment device is then expanded to its final shape, see FIG.52g , where after the pouch is sealed by suturing or stapling by meansof the fixations elements, see FIG. 52 h.

All the alternatives described above with reference to FIGS. 1-51 arealso applicable to the embodiment described with reference to FIG. 52a-1, i.e., to the embodiment where the reflux treatment device isinvaginated on the inside of the stomach wall.

FIGS. 53 a-c show an instrument for creating an invagiation of the wallof the stomach that can either be placed on the outside of the wall ofthe stomach or on the inside of the wall of the stomach depending if thereflux treatment device is place on the inside or the outside of thewall. The instrument uses vacuum to such a portion of the wall of thestomach into the cup of the instrument.

It has been described how the reflux treatment device 10 is invaginatedin the stomach wall by means of a gastroscopic instrument. Thegastroscopic instrument can be used for either placing the refluxtreatment device on the outside of the wall of the stomach as shown inFIG. 1A or on the inside of the stomach as shown in FIG. 2A. In thelatter case, the instruments will be used to make an incision in thewall of the stomach from the inside of the stomach.

It will be appreciated that abdominal operation methods can be used aswell. Such methods will now be described in with reference to FIGS.54-55. In FIG. 54 it is shown how the stomach is accessed by creating anincision 380 n the abdomen of the patient. In FIG. 55 it is shown how aninstrument 381 is inserted into the abdomen of the patient. Any of theinstruments and methods described can be selected an adapted for thispurpose. Thus, for example, the reflux treatment device can be placed onthe outside of the stomach as shown in FIG. 1A or on the inside as shownin FIG. 2A. In the later case an incision is made in the wall of thestomach.

Stimulation—Detailed Description

FIG. 56 schematically shows an embodiment of the heartburn and refluxdisease apparatus of the invention having some parts implanted in apatient and other parts located outside the patient's body. Thus, inFIG. 56 all parts placed to the right of the patient's skin 2 x areimplanted and all parts placed to the left of the skin 2 x are locatedoutside the patient's body. The apparatus of FIG. 56 comprises animplanted electric stimulation device 4, which engages the patient'scardia sphincter to provide electric connection thereto. An implantedcontrol unit 6 x controls the stimulation device 4 x via a control line8 x. An external control unit 10 x includes an external source of energyand a wireless remote control transmitting a control signal generated bythe external source of energy. The control signal is received by asignal receiver incorporated in the implanted control unit 6 x, wherebythe control unit 6 x controls the implanted stimulation device 4 x inresponse to the control signal. The implanted control unit 6 x also useselectric energy drawn from the control signal for powering thestimulation device 4 x via a power supply line 12 x.

FIG. 57 shows an embodiment of the invention identical to that of FIG.56, except that an implanted internal electric source of energy in theform of a battery 42 x is substituted for the external source of energy.Thus, an external control unit 40 x without any source of energy is usedin this embodiment. In response to a control signal from the externalcontrol unit 40 x the implanted control unit 6 x powers the stimulationdevice 4 x with energy from the battery 42 x.

FIG. 58 shows an embodiment of the invention comprising the stimulationdevice 4 x, the external control unit 10 x, and an implanted source ofenergy 236 x and an implanted switch 238 x. The switch 238 x is operatedby wireless energy released from the external source of energy of theexternal control unit 6 x to switch between an off mode, in which theimplanted source of energy 236 x is not in use, and an on mode, in whichthe implanted source of energy 236 x supplies energy for the power ofthe stimulation device 4 x.

FIG. 59 shows an embodiment of the invention identical to that of FIG.58, except that also the control unit 6 x is implanted, in order toreceive a control signal from the wireless remote control of theexternal control unit 10 x. The switch 238 x is operated by the wirelessenergy from the external source of energy 10 x to switch between an offmode, in which the implanted source of energy 236 x and the wirelessremote control of the external control unit 10 x are not in use, i.e.the control unit 6 x is not capable of receiving the control signal, anda standby mode, in which the wireless remote control is permitted tocontrol the internal source of energy 236 x, via the implanted controlunit 6 x, to supply energy for the power of the stimulation device 4 x.

FIG. 60 shows an embodiment of the invention identical to that of FIG.59, except that an energy transforming device for transforming thewireless energy into storable energy is incorporated in the implantedcontrol unit 6 x and that the implanted source of energy 236 x is of atype that is capable of storing the storable energy. In this case, inresponse to a control signal from the external control unit 10 x, theimplanted control unit 6 controls the switch 238 x to switch from an offmode, in which the implanted source of energy 236 x is not in use, to anon mode, in which the source of energy 36 x supplies energy for thepower of the stimulation device 59 x.

FIG. 61 shows an embodiment of the invention identical to that of FIG.60, except that an energy storage device 240 x also is implanted in thepatient for storing the storable energy transformed from the wirelessenergy by the transforming device of the control unit 6 x. In this case,the implanted control unit 6 x controls the energy storage device 240 tooperate the switch 238 x to switch between an off mode, in which theimplanted source of energy 236 x is not in use, and an on mode, in whichthe implanted source of energy 236 x supplies energy for the power ofthe stimulation device 4 x.

FIG. 62 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communicationpossibilities. Basically, there are the implanted stimulation device 4x, the implanted control unit 6 x and the external control unit 10 xincluding the external source of energy and the wireless remote control.As already described above the remote control transmits a control signalgenerated by the external source of energy, and the control signal isreceived by a signal receiver incorporated in the implanted control unit6 x, whereby the control unit 6 x controls the implanted stimulationdevice 4 x in response to the control signal.

A sensor 54 x may be implanted in the patient for sensing a physicalparameter of the patient, such as the pressure in the esophagus. Thecontrol unit 6 x, or alternatively the external control unit 10 x, maycontrol the stimulation device 4 x in response to signals from thesensor 54 x. A transceiver may be combined with the sensor 54 x forsending information on the sensed physical parameter to the externalcontrol unit 10 x. The wireless remote control of the external controlunit 10 x may comprise a signal transmitter or transceiver and theimplanted control unit 6 x may comprise a signal receiver ortransceiver. Alternatively, the wireless remote control of the externalcontrol unit 10 x may comprise a signal receiver or transceiver and theimplanted control unit 6 x may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the stimulation devicefrom inside the patient's body to the outside thereof. For example, thebattery 32 x may be equipped with a transceiver for sending informationon the charge condition of the battery.

Those skilled in the art will realise that the above various embodimentsaccording to FIGS. 56-61 could be combined in many different ways.

FIG. 63 illustrates how any of the above-described embodiments of theheartburn and reflux disease treatment apparatus of the invention may beimplanted in a patient. Thus, an assembly of the apparatus implanted inthe patient comprises a stimulation device in the form of a band 56 x,which is wrapped around the cardia 58 x. The band 58 x is provided withconductors that electrically contact the cardia sphincter and anoperation device 60 x for operating the stimulation device 56 x. Animplanted control unit 60 x is provided for controlling the supply ofelectricity to the band 56 x. There is an implanted energy transformingdevice 62 x for transforming wireless energy into electric energy. Thetransforming device 62 x also includes a signal receiver. An externalcontrol unit 64 x includes a signal transmitter for transmitting acontrol signal to the signal receiver of the implanted transformingdevice 62 x. The transforming device 62 x is capable of transformingsignal energy from the control signal into electric energy for poweringthe stimulation device 60 x and for energising other energy consumingimplanted components of the apparatus.

FIG. 64 shows the basic parts of a wireless remote control of theapparatus of the invention including an implanted electric stimulationdevice 4 x. In this case, the remote control is based on thetransmission of electromagnetic wave signals, often of high frequenciesin the order of 100 kHz-1 gHz, through the skin 130 x of the patient. InFIG. 64, all parts placed to the left of the skin 130 x are locatedoutside the patient's body and all parts placed to the right of the skin130 x are implanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 x is to be positioned closeto a signal receiving antenna 134 x implanted close to the skin 130 x.As an alternative, the receiving antenna 134 x may be placed for exampleinside the abdomen of the patient. The receiving antenna 134 x comprisesa coil, approximately 1-100 mm, preferably 25 mm in diameter, wound witha very thin wire and tuned with a capacitor to a specific highfrequency. A small coil is chosen if it is to be implanted under theskin of the patient and a large coil is chosen if it is to be implantedin the abdomen of the patient. The transmitting antenna 132 x comprisesa coil having about the same size as the coil of the receiving antenna134 x but wound with a thick wire that can handle the larger currentsthat is necessary. The coil of the transmitting antenna 132 x is tunedto the same specific high frequency as the coil of the receiving antenna134 x.

An external control unit 136 x comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 x is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas 132x,134 x to an implanted control unit 138 x. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 x is connected to the microprocessor thereof. The keypad isused to order the microprocessor to send digital signals to either poweror not power the stimulation device. The microprocessor starts a commandby applying a high frequency signal on the antenna 132 x. After a shorttime, when the signal has energised the implanted parts of the controlsystem, commands are sent to power the stimulation device. The commandsare sent as digital packets in the form illustrated below.

Start Pattern, 8 Bits Command, 8 Bits Count, 8 Bits Checksum, 8 Bits

The commands may be sent continuously during a rather long time period.When a new power or not power step is desired the Count byte isincreased by one to allow the implanted control unit 138 x to decode andunderstand that another step is demanded by the external control unit136 x. If any part of the digital packet is erroneous, its content issimply ignored.

Through a line 140 x, an implanted energiser unit 126 x draws energyfrom the high frequency electromagnetic wave signals received by thereceiving antenna 134 x. The energiser unit 126 stores the energy in apower supply, such as a large capacitor, powers the control unit 138 xand powers the electric stimulation device 4 x via a line 142 x.

The control unit 138 x comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136 x. The microprocessor of the control unit 138 x receives thedigital packet, decodes it and, provided that the power supply of theenergiser unit 126 x has sufficient energy stored, powers thestimulation device 4 x via a line 144 x.

Alternatively, the energy stored in the power supply of the energiserunit may only be used for powering a switch, and the energy for poweringthe stimulation device 4 x may be obtained from another implanted powersource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect said battery to the control unit 138 xin an on mode when the switch is powered by the power supply and to keepthe battery disconnected from the control unit in a standby mode whenthe switch is not powered.

Stretching—Detailed Description

Here follows detailed description of two embodiments of the inventionwhere treatment of reflux is combined with treatment of obesity. First,embodiments showing a stretching device is shown.

Invaginated in the stomach wall is to be understood as an object beingplaced inside of a cavity made of stomach wall material. Theinvagination enables stomach to stomach sutures or staplers whichenables the object of be enclosed by means of the human tissue healing.

FIG. 65 shows a first embodiment of an obesity treatment apparatus. Theapparatus comprises a stretching device 10 y implanted in a humanpatient. In FIG. 65 the stretching device 10 y is invaginated in thewall 12 y of the patient's stomach 12 y and the body of the stretchingdevice 10 y is shaped to rest against the wall 12 y of the stomach 12 yand further has an outer surface suitable to rest against this wall 12y. This means that the stretching device 10 y preferably has anessentially round shape to not damage the stomach wall. However, thestomach wall 12 y is strong so many different shapes and forms may beused.

The stretching device 10 y can be fixed to the wall 12 ay of the stomach12 y in a number of different ways. In the embodiment shown in FIG. 65,the stretching device 10 y is invaginated in the stomach wall 12 ay.After in-vagination, a number of stomach-to-stomach sutures or staplers14 y are applied to keep the in-vagination in the short term. Thisallows growth of human tissue, keeping the in-vagination in the longterm.

By enlarging the size of the stretching device, the stomach wall 12 ysurrounding the stretching device 10 y is stretched since thecircumference of the stretching device 10 y is increased. By thisstretching, receptors in the stomach wall indicate that the stomach isfull, thereby creating a feeling of satiety to the patient.Correspondingly, when the stretching device 10 y is contracted, thereceptors indicate that the stomach is not full, thereby returning thefeeling of hunger.

The expansion and contraction of the stretching device 10 y can beperformed under direct control of the patient. Alternatively, theexpansion and contraction can be performed according to a pre-programmedschedule.

Returning to FIG. 65, this figure also shows a fluid operation device,i.e., a hydraulic or pneumatic operation device suited for operating thestretching device, which in the following will be described in detail.

The stretching device 10 y forms a fluid chamber, in which fluid isallowed to flow. The stretching device 10 y thus forms an expandablechamber that can change the volume it occupies in the stomach wall,thereby forming a hydraulically or pneumatically regulated stretchingdevice 10 y.

A regulation reservoir 16 y for fluids is connected to the stretchingdevice 10 y by means of a conduit 18 y in the form of a tube. Thestretching device 10 y is thereby adapted to be regulated, preferablynon-invasively, by moving liquid or air from the regulation reservoir 16y to the chamber formed by the stretching device.

The regulation reservoir 16 y can be regulated in several ways. In theembodiment shown in FIG. 65, the regulation reservoir 16 y is regulatedby manually pressing the regulation reservoir 16 y. In other words, theregulation reservoir 16 y is regulated by moving a wall of thereservoir. It is then preferred that the regulation reservoir 16 y isplaced subcutaneously and non-invasive regulation is thereby achieved.

When the regulation reservoir 16 y is pressed, the volume thereofdecreases and hydraulic fluid is moved from the reservoir to the chamberformed by the stretching device 10 y via the conduit 18, enlarging orexpanding the stretching device 10 y. For filling and calibrating thefluid level of the apparatus an injection 1001 y port is furthermoreprovided. The injection port preferably comprises self sealing membrane,such as a silicone membrane.

It will be appreciated that instead of hydraulic operation, pneumaticoperation can be used, wherein air instead of hydraulic fluid is movedbetween the reservoir 16 y and the chamber formed by the stretchingdevice 10 y. Preferable the reservoir has a locking position to keep itin the desired position. If the patient compresses the reservoir 16 y itpreferably stays compressed and releases after pressing again.

Any kind of hydraulic solution may be used for the stretching device.The hydraulic solution may be driven by both mechanically and be poweredwith any motor or pump as well as manually.

FIG. 65 further shows a reversed servo system which comprises aregulation reservoir 16 y and a servo reservoir 90 y. The servoreservoir 90 y hydraulically controls a stretching device 10 y via aconduit 18 y. The reverse servo function is described in greater detailin FIGS. 97-100

FIG. 66a shows the apparatus according to another embodiment in which amotor 40 y is adapted to move a wall of the regulation reservoir 16 y.The powered regulation reservoir 16 y is then preferably placed in theabdomen of the patient. In this embodiment, a wireless external remotecontrol unit 34 by,cy and an external energy transmission device 34 aycan be provided to perform non-invasive regulation of the motor via anenergy transforming device 30 y, which is adapted to supply an energyconsuming operation device, in the present example the motor 40 y, withenergy.

The remote control may comprise a wireless energy transmitter. 34 aywhich also can act as a regulation device for non-invasively regulatingthe stretching device. When the regulation is performed by means of aremote control 34 y an internal power source 70 y for powering theregulating device is provided. The internal energy source 70 y can forexample be a chargeable implanted battery or a capacitor or a device forreceiving wireless energy transmitted from outside the body of thepatient. Different ways of regulating the stretching device 10 y will bedescribed below with reference to FIGS. 77-100.

The apparatus as shown in FIG. 66a further comprises a sensor 201 ysensing a parameter of the patient or the apparatus preferably connectedto the food intake of the patient. The sensor is connected to a controlassembly 42 y by means of a sensor signal transferring member 202 y. Thesensor can be used to regulate said apparatus in a completely automaticway, i.e. the apparatus responds to a sensor signal connected to thefood intake of the patient, thereby affecting the control assembly tooperate the stretching device 10 y to stretch the stomach wall 12 y andthereby creating a feeling of satiety in the patient. The sensor couldbe adapted to measure the food intake of the patient through any oftemperature, blood pressure, blood flow, heartbeats, breathing andpressure and can be placed in the stomach 12 y, esophagus 203 y or inconnection with the cardia 204 y. According to one embodiment saidsensor is a strain gauge measuring contraction and/or relaxation of thecardia 204 y.

The apparatus as shown in FIG. 66a further comprises a second conduit222 y for backflow of hydraulic fluid. The backflow is adapted to createthe desired feeling of satiety for a predetermined time whereafter thehydraulic fluid has flowed back in a quantity large enough for thestretching device not to stretch the stomach wall anymore and therebythe feeling of hunger returns to the patient. A suitable time for theprocess is between 1 and 6 hours. According to other embodiments thebackflow takes place in the main conduit 18 y by means of a valve systemconnected to said conduit 18 y.

For filling and calibrating the fluid level of the apparatus aninjection 1001 y port is furthermore provided. The injection port 1001 ypreferably comprises self sealing membrane, such as a silicone membrane.

FIG. 66b shows the apparatus according to the embodiment of FIG. 66a ,in a second state in which the stretching device 10 y is expanded andthereby stretches the stomach wall 12 y.

FIG. 67a shows an embodiment, wherein two stretching devices 10″y areprovided. Both stretching devices 10″y work according to the principlesdescribed above with reference to FIG. 65. They can be adapted topostoperatively and non-invasively be regulated and adapted to from timeto time regulate different stretching devices to at a first time stretcha first part of the stomach wall and at a second time stretch a secondpart of the stomach wall.

Such a stretching device 10 y may be used for keeping electronics and/oran energy source and/or hydraulic fluid. Hydraulic fluid from thatdevice may be distributed to several smaller stretching device areas tovary the stretching area from time to time avoiding any possible morepermanent stretching effect of the stomach wall. Even mechanicallyseveral stretching areas may be used. The embodiment according to FIG.67a further comprises a hydraulic valve shifting device 54 y, implantedin the patient, for shifting between operating the first and the secondstretching device 10″y. The alternating creates a more sustainabledevice since the receptors in the stomach wall is stimulated gets alonger time of recovery between the stretches.

In FIG. 67a the system is a manual system controlled by the patient asdescribed before with reference to FIG. 65, whereas in FIG. 67b thesystem is energized using wireless energy as described before withreference to FIG. 66 a.

FIG. 68a-e shows different embodiments of the stretching device 10 yadapted to be implanted in a patient. The stretching device 10 ycomprises a surface adapted to be in contact with the stomach wall 12 ywhen the device is invaginated in the stomach wall. FIG. 68b shows anembodiment of the stretching device in which the stretching devicecomprises a fixating member 206 y for suturing or stapling thestretching device to the stomach wall. The fixating member 206 y couldcomprise holes for receiving said sutures or staplers 14 y, or thefixation device 206 y could be penetratable such that the sutures orstaplers can penetrate the stomach wall and the fixation device 206 y.68 c shows the stretching device 10 y according to an embodiment inwhich the stretching device 10 y comprises an inlet member 207 y forfilling said device with a fluid. Said inlet member is preferablyconnected to a hydraulic conduit 18 y adapted to be invaginated in thestomach wall 12 y. FIG. 68d shows the stretching device 10 y accordingto an embodiment in which the stretching device 10 y comprises a holdingmember 208 adapted to connect to an insertion device when saidstretching device 10 y is inserted into an invaginated pouch of thestomach wall 12 y. FIG. 68e shows the stretching device 10 y accordingto an embodiment in which the stretching device has a slightly oval oregg-shaped shape. FIG. 68e furthermore shows the hydraulic conduit 18attached to said stretching device 10 y. FIG. 68f shows the stretchingdevice 10 y according to an embodiment in which the stretching device isinflatable by a fluid transported through the conduit 10 y. According toone embodiment shown in FIG. 68f the conduit comprises two sections 18ay,by wherein the first section 18 ay is used to pull the stretchingdevice 10 y into place, and to fill the device 10 y with a suitablefluid, whereas the second section 18 by is used for the operation ofsaid device 10 y. FIG. 68g shows the stretching device 10 y according tothe embodiment of FIG. 68f in a deflated state. The stretching device 10y is inserted through a hole in the stomach wall 12 y in its deflatedstate whereafter the device 10 y is filled with a suitable fluid foroperation. FIG. 68h shows the stretching device 10 y according to anembodiment in which the stretching device 10 y comprises two movablewall portion 223 ay,by, which are moveable by means of a bellowsstructure 209 y made of a flexible material. FIG. 68i shows thestretching device according to an embodiment where the stretching deviceis expandable by means of four expandable sections 210 y symmetricallyplaced on four places along the surface of the stretching device, asshown in the section image of FIG. 68i . The expandable sections 210 yare made of a flexible material for allowing said sections 210 y toexpand when said stretching device 10 y is filled with a hydraulicfluid.

Surface Structure of Implants

The general structure of any implanted device of the invention will nowbe described with reference to FIG. 69 a-k. The present inventionconcerns an implant, adapted to post-operatively be adjustable andcomprising at least one expandable section, wherein the implant isadapted to be adjustable between a first collapsed state and a secondexpanded state. In the first collapsed state the expandable section iscollapsed, and in the second expanded state, the expandable section isexpanded. The outer surface of said expandable section does at leastpartly comprise a surface structure having elevated areas alternatingwith lowered areas. The expandable section is adapted to have, in atleast one of said first collapsed and second expanded states a firstdistance between adjacent elevated areas sufficiently extended toprevent growth of fibrotic tissue from directly interconnecting adjacentelevated areas to an extent that compromises the adjustability between afirst collapsed and a second expanded state of said implant. Theexpandable section further comprising connecting areas between adjacentelevated and lowered areas, further adapted to have, in at least one ofsaid first collapsed and second expanded states, a second distancebetween adjacent connecting areas sufficiently extended to preventgrowth of fibrotic tissue from directly interconnecting adjacentconnecting areas to an extent that compromises the adjustability betweena first collapsed and a second expanded state of said implant.

According to one embodiment the expandable section is hollow orcomprises a hollow body.

According to another embodiment the implant is substantially completelyhollow or comprises a hollow body extending along substantially thecomplete length and/or complete volume of said implant.

Fibrotic tissue can often have an extension or thickness of about 0.5 mmto about 1.5 mm and hence the distances between relevant surfaces of theelements of the surface structure are suitably greater than about 3 mm,hence greater than about 2×1.5 mm. But depending on the circumstancesalso distances greater than about 1.0 mm to about 3 mm may besufficient. In cases where the fibrotic tissue can be expected to havean extension or thickness greater than about 1.5 mm the distancesbetween relevant surfaces of the elements of the surface structure areadapted in a suitable manner.

The surface structure may comprise elevated and lowered areas and it maybe suitable that also a distance between the different planes of theelevated and lowered areas is bigger than a certain threshold tofacilitate the collapsible and/or expandable functionality of theimplant. If said distance is too small, the collapsible and/orexpandable functionality of the implant may be limited. A suitableinterval for said distance is around 0.5 to 10 mm, more suitable around2-8 mm and most suitable around 3-7 mm The surface structure maycomprise different geometrical elements or shapes and any combination ofsuch elements or shapes as long as the above mentioned conditions forthe distances can be met. The surface structure may e.g. comprise ridgesand grooves of different shapes. The ridges and grooves may each have across-section that is e.g. wedge-shaped, polygonal, square-formed,pyramidal-shaped, truncated pyramidal-shaped or. Further may the ridgesand grooves have cross-sections of different shapes. The surfacestructure may as well in general comprise a bellows-shaped structure ora surface structure where geometrical objects of the same or differentkind(s) are placed on a surface. The geometrical objects may bepractically randomly placed on the surface or according to some scheme.

One type of implants where this type of surface structure may besuitable, is implants where the implant should have the ability tochange shape and/or size substantially. Hence, this is a case where thepresence of fibrotic tissue substantially could hinder or impede thefunction of the implant. But the surface structure may be used by anyimplant where the characteristics of the surface structure would beadvantageous for the implant.

A first distance 708 a between two elevated areas 701, see FIG. 69a , islong enough so as to prevent growth of fibrotic tissue directlyconnecting two adjacent elevated areas 707. That is, it may be possiblethat fibrotic tissue grows on the surface of the elevated and loweredareas 701, 702 and the connecting areas 704. However, thanks to theextension of the first distance 708 a, fibrotic tissue is prevented fromgrowing directly from one elevated area 701 to another adjacent elevatedarea 701.

With the expression “growing directly from one elevated area 701 toanother elevated area 701” it is e.g. meant that fibrotic tissue growsfrom one elevated area 701 to another while not or only to a smallextent growing on a connecting area 704. As indicated at 704 a in FIG.69i , the first distance 708 a may be measured within an interval 704 afrom the level of an elevated area 701. The expression “growing directlyfrom one elevated area 701 to another elevated area 701” also includesthe situation that fibrotic tissue grows on adjacent areas. e.g. twoadjacent connecting areas 704, with such a thickness that the fibrotictissue from each adjacent area meet and bridge the distance or spacebetween two elevated areas 701. In such a situation the space betweentwo elevated areas 701 may be partly or completely filled with fibrotictissue.

It may be advantageous that also a second distance 708 b correspondingto the extension of a lowered area 702 has an extension great enough soas to prevent fibrotic tissue from growing directly from one connectingarea 704 to another connecting area 704. With the expression “growingdirectly from one connecting area 704 to another connecting area 704” itis meant that fibrotic tissue grows from one connecting area 704 toanother while not or only to a small extent growing on a lowered area702.

In FIG. 69i a surface structure comprising elevated and lowered areashas been shown, but apart from elevated and lowered areas also manyother geometrical structures may be used where it is possible to fulfillthe above mentioned prevention of growth of fibrotic tissue. Inparticular, the above mentioned prevention of growth of fibrotic tissuebetween elevated areas and between connecting areas.

Some examples of such other geometrical structures are shown in FIGS.69i-k . In a surface structure comprising ridges and grooves, the ridgesand grooves may also have different sections, some examples are shown inFIGS. 69b -69 e.

Referring mainly to FIGS. 69a and b some expressions and aspects willnow be explained. In this application the concept of a first distance708 a. 718 a between adjacent elevated areas 701, 710 is used. With sucha first distance 708 a, 718 a it is meant a distance that is measuredsubstantially from the edge 706, 714 of one elevated area 701, 710 tothe edge 706, 714 of an adjacent elevated area 701, 710. Measuredsubstantially from the edge means that the measurement may be donewithin a first interval 704 a from the level of an elevated area 701,710, the first interval 704 a extending from the level of an elevatedarea 701, 710 towards the level of an adjacent lowered area 702, 712.

In this application also the concept of a second distance 708 b, 718 bbetween adjacent connecting areas 704, 716 is used. With such a seconddistance 708 b, 718 b it is meant a distance that is measuredsubstantially from the connection point between a connecting area 704,716 and a lowered area 702, 712 to another connection point involving anadjacent connecting area 704, 716. Measured substantially from theconnection point means that the measurement may be done within a secondinterval 704 b from the level of a lowered area 702, 712, the secondinterval 704 b extending from the level of a lowered area 702, towardsthe level of an adjacent elevated area 701, 710.

With elevated and lowered areas it is meant areas that lie in differentplanes 703, 705, 720, 722 where the planes are separated by a distance707, 724, 728. The planes may be parallel or substantially parallel butmay also be non-parallel. If the planes are parallel, defining adistance between them is trivial. If the planes are non-parallel (as inFIG. 2a ) a distance between the planes may be defined by a normal 724,728 to one of the planes 720, 722 where the normal extend to a point onan area in another plane 722, 726 and the distance between the planes isequal to the extension of the normal 724, 728. As seen in FIG. 2a thenormal 724, 728 extends from a plane 720, 722 to a point which isapproximately equally distant from the edges of an area. There are twopossible ways to define the normal or distance between the planes.Taking normal 728 as example, one may define the normal as in 728 a orin 728 b. It may be suitable to define the distance between two planesas the extension of the longest normal, the distance between the planes720 and 722 would then be equal to the extension of normal 728 a. Thisdefinition will be used hereafter.

The elevated and lowered areas may have different shapes, they may beplane or substantially plane but they may also have some kind of curvedshape.

The elevated areas 701, 710 connect to adjacent lowered areas 702, 712by means of connecting areas 704, 716. The connection betweenelevated/lowered areas and connecting areas 704, 716 may comprise aradius of different sizes, bigger or smaller radii. When the radius isvery small there will substantially be an edge 706, 714 connecting theareas.

The expression “expandable section” implies that said section also iscollapsible.

Suitably the implantable device 10 at least partly comprises materialswhich have a high degree of biocompatibility, such materials may becalled physiologically inert, biologically inert or biocompatible.

Referring in particular to FIGS. 69a-b , in the surface structure 700there may advantageously be a specified first distance 708 a, 718 abetween adjacent elevated areas 701, 710. The distance between adjacentelevated areas 701, 710 is chosen so that fibrotic tissue cannot bridgethe first distance 708 a, 718 a between adjacent elevated areas 701,710. Hence, the first distance 708 a, 718 a between adjacent elevatedareas 701, 710 is advantageously big enough to prevent the formation offibrotic tissue that bridges adjacent elevated areas 701, 710.

As mentioned before, there may advantageously be a specified seconddistance 708 b. 718 b between adjacent connecting areas 704, 716. Thesecond distance 708 b, 718 b between adjacent connecting areas 704, 716is chosen so that fibrotic tissue can not bridge the second distance 708b, 718 b between adjacent connecting areas 704, 716. Hence, the seconddistance 708 b, 718 b between adjacent connecting areas 704, 716 isadvantageously big enough to prevent the formation of fibrotic tissuethat bridges adjacent connecting areas 704, 716.

It may also be advantageous that a third distance 707, 724, 728 abetween the different planes 703, 705, 720, 722, 726 of the elevated andlowered areas is bigger than a certain threshold to facilitate thecollapsible and/or expandable functionality of the implant. If the thirddistance 707, 724, 728 a is too small the collapsible and/or expandablefunctionality of the implant may be limited. A suitable interval for thethird distance 707, 724, 728 a is 0.5 to 10 mm, more suitable 2-8 mm andmost suitable 3-7 mm. Also regarding the aspect that the fibrotic tissueshould not impede the collapsible/expandable functionality of theimplantable device it is advantageous that the distance 707, 724, 728 ais not too small, but suitably in the interval/s as mentionedpreviously.

The surface structure 700 may include objects or elements of differentgeometrical shapes, for example ridges of different shapes, embossmentsof different shapes and other objects which enable a surface structureas described herein. The area of the elevated areas 701, 710 may be verysmall while still resulting in a surface structure that has the desiredfunctionality. The area of the elevated areas 701, 710 may even bealmost zero, as exemplified in FIG. 2d . Whereas FIGS. 1 and 2 a-2 dshow cross sections of examples of surface structures 700, FIGS. 69i-kshow examples of different surface structures 700 in perspective. Theobjects or elements in the surface structure 700 may be placed in rows,ordered in some other way, or may be more or less randomly distributedover the surface of the implant. Different types of objects may also beused together in the surface structure 700, e.g. a combination ofpyramid shaped and cone shaped objects together with ridges of someshape.

In FIGS. 69f-h an embodiment of an implant 10 is shown where a surfacestructure 700 is used, the implant 10 is not shown in full. FIG. 69fshows a longitudinal section of the implant 10 where 740 denotes thesurface structure on the upper side of the implant 10 and 742 denotesthe surface structure on the under side of the implant 10. As shown inFIG. 69f the surface structure 742 on the under side may have a greaterextension than the surface structure 740 on the upper side of the penileprosthesis. This gives the implant 10 an up-bent position when theimplant 10 is expanded. The surface structures 140 and 142 are oneexample of a bending portion. FIG. 69g shows a cross section of theimplant 10 where the implant 10 includes a waist portion 744, where thewaist portion comprises waist surface structures 746 and 748. The waistportion with the waist surface structures 746 and 748 make the implant10 expandable also in the radial direction. The implant 10 may also havea cross section as shown in FIG. 69g comprising a waist portion 744having four waist surface structures 750, 752, 754, 756 furtherfacilitating the ability of the implant 10 to be expandable also in theradial direction. The cross sections in FIGS. 69g and h are taken alongthe line A1-A2 in FIG. 69 f.

Further Embodiments Comprising a Stretching Device.

Further embodiments of the inventions that disclose the treatment ofobesity by stretching the stomach will now be described.

FIG. 70a illustrates a stretching device 10 y provided with an inletport 18 by. The stretching device 10 is invaginated in the stomach wall12 y and the inlet port 18 by is available for connection to a tube orthe like from the abdominal area of the patient. The tube or conduit 18y can preferably be connected to the control unit 42 y or an injectionport 1001 y.

FIG. 70b illustrates an invaginated stretching device 10 y wherein,instead of an inlet port, a conduit 18 y or electrical lead extends intothe abdominal area of the patient.

FIG. 70c shows a section of the stretching device 10 y and part of thestomach in which the stretching device 10 y is invaginated. The conduit18 y or electric lead is invaginated in the stomach wall 12 y by meansof stomach to stomach sutures or staplers 14 y which creates an entirelysealed pouch of stomach wall tissue in which the stretching device 10 yis placed. The conduit 18 y or electric lead is thereby tunneled in thestomach wall 12 y between the inlet port 18 by and the volume fillingdevice 10 y.

It has been shown that the shape of the stretching device 10 y can takemany different forms. It will be appreciated that also the material ofthe stretching device 10 y can vary. It is preferred that the stretchingdevice 10 y is provided with a coating, such as a Parylene,polytetrafluoroethylene (PTFE), or polyurethane coating, or acombination of such coatings, i.e., a multi-layer coating. This coatingor multi-layer coating improves the properties of the stretching device,such as its resistance to wear.

In another embodiment shown in FIG. 71, the stretching device 110 yworks according to a different principle from that described above withreference to FIGS. 65-70. The stretching device 110 y here comprises afirst fixation portion 110 ay adapted to have a first fixation at afirst position on the stomach wall 12 y and a second fixation portion110 by adapted to have a second fixation at a second position on thestomach wall 12 y These fixation portions 110 ay,by, which preferablyhave an essentially round shape and preferably are adapted to beinvaginated in the stomach wall 12 y, are attached to the distal end ofa respective leg 211 y, which in turn are attached at their respectiveproximal end to an operation device, such as a motor 40 y. According tothe embodiment shown in FIG. 71 the motor is a hydraulic motor,comprising a hydraulic piston, which is connected to a manual operationdevice described previously with reference to FIG. 65. The hydraulicpiston affects the legs through their connection with a joint 212 yplaced in the extremity of the leg. The stretching device 110 y isenclosed in a housing 214 y protecting the device from the in growth offibrotic tissue which potentially could damage the function of saiddevice 110 y. However it is equally conceivable that the motor isanother hydraulic motor, a pneumatic motor or an electrical motor.

The stretching device 110 y is adapted to increase the distance betweenthe first position and the second position on the stomach wall 12 y,thereby stretching the stomach wall 12 y. The first and/or secondfixation portions 110 ay, 110 by are adapted to at least partly beinvaginated in the stomach wall 12 y with stomach-to-stomach sutures orstaplers 14 y holding the fixation portions 110 ay,by in place insuspension in relation to the stomach wall 12 y.

Of course the first and second positions may be sutured or fixated tothe stomach wall in many possible ways and the invention covers allpossibilities to distend the stomach wall by moving two portions of thestomach wall away from each other and thereby first fixating the deviceto at least two positions on the stomach wall. However, the softsuspended connection to the stomach wall 12 y where fibroticstomach-to-stomach tissue helps to give a long term stable position isto prefer.

Of course just expanding an in-vaginated part of the stomach alsostretches away the stomach wall 12 y which also may be achieved bothmechanically, hydraulically, pneumatically and both being powered with amotor or pump or by manual force.

Any kind of mechanical construction may be used and the mechanicalembodiment disclosed is one example. Any mechanical construction drivenby mechanically or hydraulically or any pneumatic construction may beused. Any motor or any pump or moving material changing form whenpowered may be used to achieve the simple goal of stretching a part ofthe stomach wall by moving at least two portions of the stomach wallaway from each other.

FIG. 72 shows the stretching device 110 y according to an embodiment inwhich the stretching device is controlled from an implantable controlassembly 42 y to which sensor input, as described earlier, in received.The stretching device is then regulated through the conduit 18 y using apump 44 y, connected to at least one fluid reservoir 16 y, 46 y, andpowered from a energy transforming member 30 y connected to an receiverof wireless energy 205 y, placed under the skin 36 y, or an implantableenergy source 70 y, such as a rechargeable battery.

In a variant, shown in FIG. 73a , the first and/or second fixationportions 210 ay, 210 by, respectively, exhibit a structure adapted to bein contact with the stomach wall 12 y to promote growth in of humantissue to secure the long term placement of the stretching device 110 yattached to the stomach wall 12 y. This structure preferably comprises anet like structure 213 y. The fixation portions 210 ay, 210 by may beadapted to keep the stretching device 110 y in place by sutures orstaplers between the fixation portion and the stomach wall 12 y tosecure the short term placement of the stretching device 110 y. In turnsof mechanical operation the stretching device 110 y according to theembodiment shown in FIG. 73a functions in accordance with the devicedescribed with reference to FIG. 71. FIG. 9 by shows a fixation device213 y comprising a net like structure adapted to propagate the growth-inof fibrotic tissue to fixate the two fixating portions to the stomachwall 12 y.

FIG. 73c shows the stretching device according to the embodiment of FIG.73a in a second state, in which the two fixating portions have beenseparated from each other and the stomach 12 y has been stretched.

FIG. 74a shows the stretching device according to an embodiment in whichthe stretching device is an electrical mechanical stretching deviceconnected to a control assembly 42 y through a power supply line 32′y.The power supply line 32 y is connected to a power transforming device30 y in contact with a receiver of wireless energy 205 y, such as acoil, which receives energy from a transmitter of wireless energy 34 ay.The control assembly may furthermore comprise a battery 70 y for storingenergy received from the wireless energy transmission device 34 ay. Thecontrol assembly receives input from a sensor 201 y, which according tothis embodiment is a strain gauge measuring the contraction and/orrelaxation of the cardia 204 y.

FIG. 74b shows the stretching device 10 y in further detail. Thestretching device 10 y comprises a housing having a bellows structure209 y made of a flexible material so as to enable the wall portions tomove. The power supply line 32 y is connected to a stator 217 y of anelectrical motor, said motor further comprising a rotor 218 y whichcomprises a thread that interacts with a displaceable member 219 ycomprising a corresponding thread. The displacing member is rotatablyfixated to a housing contacting member 220 y which pushes against thehousing for affecting the volume of the stretching device and therebystretching the stomach 12 y.

FIG. 74c shows the stretching device according to FIG. 10 by in a secondstate, in which the stretching device is expanded and thereby stretchesthe stomach wall 12 y.

FIG. 75a shows an embodiment in which a device adapted to treat refluxdisease is combined with the stretching device according to any of theembodiments above. After invagination of the device 410 in the fundus416, a fixation consisting of a number of stomach-to-stomach sutures orstaples 422 a is applied to keep the invagination intact in the shortterm. A second fixation consisting of a number of sutures or staples 422b is provided to hold the device 410 in position above the cardia 414.The sutures or staples 422 b are applied between the wall of the fundus416 and the wall of the esophagus 424 y. Additionally, a third fixationin the form of sutures or staples 422 cy may be provided between thewall of the fundus 416 and the diaphragm 418, again, to hold the device410 in position above the cardia 414.

In this fourth embodiment depicted in FIG. 75a , the size of the refluxdisease treatment device 410 can be regulated while being implanted. Thereflux disease treatment device 410 is associated with a subcutaneoushydraulic reservoir 452 connected to the reflux disease treatment device410, by a lead 452 b whereby a non-invasive regulation can be performedby manually pressing the reservoir 452. Pressing the reservoir 452displaces hydraulic fluid from the reservoir 452 to the smaller chambers410 b via the lead 452 b. The reflux disease treatment device 410 is, inturn, connected to one or more smaller chambers 410 b. In this manner,the patient may adjust the size of the reflux treatment device 410 in amanner adapted to the treatment.

Furthermore, the embodiment above may alternatively be used to alsotreat obesity. The device may, in this embodiment, be adapted to treatobesity by using the volume of the reflux disease body to contain afluid, and further using one or several smaller chambers 410 b connectedto the device body with a pump to be filled with fluid to expand andthereby stretch the fundus wall to create satiety. The small chambers410 b are also adapted to be invaginated to in the fundus stomach wall,and when filled with fluid, an expansion of the stomach occurs thatresults in human sensor feedback creating satiety. The subcutaneoushydraulic reservoir/pump enables the patient to conveniently pumphydraulic fluid to fill the small chambers 410 b to create a feeling ofsatiety as he or she wishes.

An alternative embodiment is shown in FIG. 75b . This embodiment issubstantially similar to the one shown in FIG. 75a but differs in howthe reflux treatment device 410 and chambers 410 b are controlled. Here,the chambers 410 b are nor controlled by a subcutaneous pump but apowered internal control unit 456. The internal control unit 456comprises means for the patient to control the device 410 in how itshall be used regarding treatment of reflux and/or obesity. It may alsocomprise means of supplying power to the device.

The internal control unit 456 may comprise a battery 470, an electricswitch 472, a motor/pump 444, a reservoir 452, an injection port 1001.An energy transmission device 34 with a remote control is adapted forcontrolling and powering the device. The items being selected dependingon the circumstances. e.g. if the device is electrically, hydraulically,pneumatically or mechanically operated. The device 410 may be used forkeeping electronics and/or an energy source and/or hydraulic fluid.

FIG. 76a shows an adjustable volume filling device 810 y, which isinvaginated in the stomach wall of a patient's stomach 12 y. The volumefilling device 810 y is adapted to take up space in the stomach andthereby reduce the volume in which food can be placed. Additionally, anadjustable stretching device 10 y according to any of the embodiments isinvaginated in the stomach fundus wall of the patient. It is preferredthat the volume filling device 810 y is substantially larger than thestretching device 10 y.

The volume filling device 810 y and the stretching device 10 y are influid communication with each other via a first fluid tube 52 y, inwhich a pump 54 y is provided. The pump 54 y is under the control froman energy transforming device 30 y, which is adapted to supply the pump54 y with energy via a power supply line 56. The energy transformingdevice 30 is also connected to a sensor 201 y provided in the esophagusof the patient so that food intake can be detected.

The volume filling device 810 y and the stretching device 10 y are alsoin fluid communication with each other via a second fluid tube 58 y,which preferably has a smaller cross-sectional area than the first fluidtube 52 y.

The operation of this arrangement is as follows. The volume fillingdevice 810 y functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12 y.Additionally, when the stretching device 10 y is enlarged by pumpingfluid from the volume filling device 810 y and to the stretching device10 yby means of the pump 54 y, the stomach fundus wall is stretched,creating a feeling of satiety for the patient. Thus, for example whenfood intake is detected by means of the sensor 201 y, fluid isautomatically pumped into the stretching device 10 y to increase thefeeling of satiety and thereby limit the food intake.

When fluid has been injected into the stretching device 10 y, theinternal pressure therein is higher than the internal pressure in thevolume filling device 810 y. This difference in pressure will create aflow of fluid in the second, preferably narrower tube 58 y from thestretching device 10 y to the volume filling device 810 y. The flow ratewill be determined by among other things the difference in pressure andthe cross-sectional area of the second tube 58 y. It is preferred thatthe second tube is so dimensioned, that the pressures in the volumefilling device 810 y and the stretching device 10 y will return toequilibrium after 3 hours after fluid has been injected into thestretching device 10 y to create the feeling of satiety.

In this embodiment, the function of the second tube 58 y is to allowfluid to return from the stretching device 10 y to the volume fillingdevice 810 y. It will be appreciated that this function also can beperformed by the pump 54 y in the first tube 52 y and that the secondtube 58 y then can be omitted.

Yet an alternative embodiment of an apparatus for treating obesity willnow be described with reference to FIG. 76b , which shows a stomach 12 yof a patient who is treated for obesity. The apparatus comprises avolume filling device 810 y in the form of an inflatable device 10 ywhich is invaginated in the wall 12 ay of the patient's stomach 12 y.However, in this case the invagination has been performed in the fundus,i.e., the upper portion of the stomach, where the number of receptors inthe stomach wall is large, and the inflatable device functions as astretching device for part of the stomach fundus wall.

A regulation reservoir for fluids is connected to the inflatable deviceby means of a conduit 18 y in the form of a tube. The inflatable device810 y is thereby adapted to be regulated, preferably non-invasively, bymoving liquid or air from the regulation reservoir to the chamber formedby the inflatable device 810 y. The regulation of the inflatable device810 y preferably comprises a reversed servo, i.e., a small volume isactuated for example by the patient's finger and this small volume is inconnection with a larger volume, i.e., the regulation reservoir.

Thus, the inflatable device 810 y is placed outside the stomach wall andis adapted to stretch a part of the stomach fundus wall, therebyaffecting the patient's appetite. By enlarging the size of thestretching device, the stomach fundus wall surrounding the inflatablestretching device 810 y is stretched since the circumference of theinflatable stretching device 810 y is increased. By this stretching, thereceptors in the stomach wall indicate that the stomach is full, therebycreating a feeling of satiety to the patient. Correspondingly, when thestretching device 810 y is contracted, the receptors indicate that thestomach is not full, thereby returning the feeling of hunger. It will beappreciated that this embodiment combines the effects of both reducingthe volume of the stomach food cavity and stretching part of the stomachwall 12 y, thereby increasing the treatment effect.

The expansion and contraction of the stretching device 810 y can beperformed under direct control of the patient. Alternatively, theexpansion and contraction can be performed according to a pre-programmedschedule.

In a preferred embodiment, shown in FIG. 76c , a sensor 201 y isprovided at a suitable position, such as at the esophagus. The volumefilling device 810 y in the form of the inflatable stretching device issimilar to the one shown in FIG. 76b . By providing one or more sensors,the apparatus for treating obesity can be automated in that the size ofthe volume filling device 810 y in the form of the inflatable stretchingdevice is adjusted depending on the amount of food entering the foodcavity of the stomach. The fluid is thereby moved between the inflatablevolume filling device 810 y and a fluid reservoir.

System

A obesity treatment system that can be combined with the above-mentionedsystem for treating reflux, generally designated 28 and comprising astretching device as described above will now be described withreference to FIGS. 77-93. The system 28 can be combined with or be thesame as the system 28 for treating reflux in FIGS. 1-64.

The system of FIG. 77 comprises a stretching device 10 y placed in theabdomen of the patient. An internal energy source in the form of animplanted energy transforming device 30 is adapted to supply energyconsuming components of the obesity treatment system with energy via apower supply line 32. An external energy transmission device 34 includesa wireless remote control transmitting a wireless signal which isreceived by a signal receiver, which may be incorporated in theimplanted energy transforming device 30 or be separated therefrom. Theimplanted energy transforming device 30 transforms energy from thesignal into electric energy which is supplied via the power supply line32.

The system of FIG. 77 is shown in a more generalized block diagram formin FIG. 79, wherein the patient's skin 36, generally shown by a verticalline, separates the interior of the patient to the right of the linefrom the exterior to the left of the line.

FIG. 77 shows a simplified block diagram showing the stretching device10 y, the energy transforming device 30 powering the stretching devicevia power supply line 32, and the external energy transmission device34.

FIG. 78 shows an embodiment of the invention identical to that of FIG.81, except that a reversing device in the form of an electric switch 38operable by polarized energy also is implanted in the patient forreversing the stretching device 10 y. The wireless remote control of theexternal energy transmission device 34 transmits a wireless signal thatcarries polarized energy and the implanted energy transforming device 30transforms the wireless polarized energy into a polarized current foroperating the electric switch 38. When the polarity of the current isshifted by the implanted energy transforming device 30 the electricswitch 38 reverses the function performed by the stretching device 10 y.

FIG. 79 shows an embodiment of the invention identical to that of FIG.78, except that an operation device 40 implanted in the patient forregulating the stretching device 10 y is provided between the implantedenergy transforming device 30 and the stretching device 10 y. Thisoperation device can be in the form of a motor 40, such as an electricservomotor. The motor 40 is powered with energy from the implantedenergy transforming device 30, as the remote control of the externalenergy transmission device 34 transmits a wireless signal to thereceiver of the implanted energy transforming device 30.

FIG. 80 shows an embodiment of the invention identical to that of FIG.81, except that it also comprises an operation device is in the form ofan assembly 42 including a motor/pump unit 78 and a fluid reservoir 46is implanted in the patient. In this case the stretching device 10 y ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 44 from the fluid reservoir 46 through a conduit 48 to thestretching device 10 y to operate the stretching device, and hydraulicfluid is pumped by the motor/pump unit 44 back from the stretchingdevice 10 y to the fluid reservoir 46 to return the stretching device toa starting position. The implanted energy transforming device 30transforms wireless energy into a current, for example a polarizedcurrent, for powering the motor/pump unit 44 via an electric powersupply line 50.

Instead of a hydraulically operated stretching device 10 y, it is alsoenvisaged that the operation device comprises a pneumatic operationdevice. In this case, pressurized air can be used for regulation and thefluid reservoir is replaced by an air chamber and the fluid is replacedby air.

In all of these embodiments the energy transforming device 30 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the device.

The external energy transmission device 34 is preferably wireless andmay include a remotely controlled control device for controlling thedevice from outside the human body.

Such a control device may include a wireless remote control as well as amanual control of any implanted part to make contact with by thepatient's hand most likely indirect for example a button to press placedunder the skin.

FIG. 81 shows an embodiment of the invention comprising the externalenergy transmission device 34 with its wireless remote control, thestretching device 10 y, in this case hydraulically operated, and theimplanted energy transforming device 30, and further comprising ahydraulic fluid reservoir 52, a motor/pump unit 44 and an reversingdevice in the form of a hydraulic valve shifting device 54, allimplanted in the patient. Of course the hydraulic operation could easilybe performed by just changing the pumping direction and the hydraulicvalve may therefore be omitted. The remote control may be a deviceseparated from the external energy transmission or included in the same.The motor of the motor/pump unit 44 is an electric motor. In response toa control signal from the wireless remote control of the external energytransmission device 34, the implanted energy transforming device 30powers the motor/pump unit 44 with energy from the energy carried by thecontrol signal, whereby the motor/pump unit 44 distributes hydraulicfluid between the hydraulic fluid reservoir 52 and the stretching device10 y. The remote control of the external energy transmission device 34controls the hydraulic valve shifting device 54 to shift the hydraulicfluid flow direction between one direction in which the fluid is pumpedby the motor/pump unit 44 from the hydraulic fluid reservoir 52 to thestretching device 10 y to operate the stretching device, and anotheropposite direction in which the fluid is pumped by the motor/pump unit44 back from the stretching device 10 y to the hydraulic fluid reservoir52 to return the stretching device to a starting position.

FIG. 82 shows an embodiment of the invention identical to that of FIG.81, except that an internal control unit 56 controlled by the wirelessremote control of the external energy transmission device 34, anaccumulator 58 and a capacitor 60 also are implanted in the patient. Theinternal control unit 56 arranges storage of electric energy receivedfrom the implanted energy transforming device 30 in the accumulator 58,which supplies energy to the stretching device 10 y. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 either releaseselectric energy from the accumulator 58 and transforms the releasedenergy via power lines 62 and 64, or directly transforms electric energyfrom the implanted energy transforming device 30 via a power line 66,the capacitor 60, which stabilizes the electric current, a power line 68and the power line 64, for the operation of the stretching device 10 y.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the stretching device 10 y to stretch the stomachaccording to a pre-programmed time-schedule or to input from any sensorsensing any possible physical parameter of the patient or any functionalparameter of the device.

In accordance with an alternative, the capacitor 60 in the embodiment ofFIG. 18 may be omitted. In accordance with another alternative, theaccumulator 58 in this embodiment may be omitted.

FIG. 83 shows an embodiment of the invention identical to that of FIG.77, except that a battery 70 for supplying energy for the operation ofthe stretching device 10 y and an electric switch 72 for switching theoperation of the stretching device 10 y also are implanted in thepatient. The electric switch 72 is operated by the energy supplied bythe implanted energy transforming device 30 to switch from an off mode,in which the battery 70 is not in use, to an on mode, in which thebattery 70 supplies energy for the operation of the stretching device 10y.

FIG. 84 shows an embodiment of the invention identical to that of FIG.83, except that an internal control unit 56 controllable by the wirelessremote control of the external energy transmission device 34 also isimplanted in the patient. In this case, the electric switch 72 isoperated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 56 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 56 to releaseelectric energy from the battery 70 for the operation of the stretchingdevice 10 y.

FIG. 85 shows an embodiment of the invention identical to that of FIG.84, except that an accumulator 58 is substituted for the battery 70 andthe implanted components are interconnected differently. In this case,the accumulator 58 stores energy from the implanted energy transformingdevice 30. In response to a control signal from the wireless remotecontrol of the external energy transmission device 34, the internalcontrol unit 56 controls the electric switch 72 to switch from an offmode, in which the accumulator 58 is not in use, to an on mode, in whichthe accumulator 58 supplies energy for the operation of the stretchingdevice 10 y.

FIG. 86 shows an embodiment of the invention identical to that of FIG.85, except that a battery 70 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 controls theaccumulator 58 to deliver energy for operating the electric switch 72 toswitch from an off mode, in which the battery 70 is not in use, to an onmode, in which the battery 70 supplies electric energy for the operationof the stretching device 10 y.

Alternatively, the electric switch 72 may be operated by energy suppliedby the accumulator 58 to switch from an off mode, in which the wirelessremote control is prevented from controlling the battery 70 to supplyelectric energy and is not in use, to a standby mode, in which thewireless remote control is permitted to control the battery 70 to supplyelectric energy for the operation of the stretching device 10 y.

It should be understood that the switch should be interpreted in itsbroadest embodiment. This means an FPGA or a DA converter or any otherelectronic component or circuit may switch power on and off preferablybeing controlled from outside the body or by an internal control unit.

FIG. 87 shows an embodiment of the invention identical to that of FIG.83, except that a motor 40, a mechanical reversing device in the form ofa gear box 74, and an internal control unit 56 for controlling the gearbox 74 also are implanted in the patient. The internal control unit 56controls the gear box 74 to reverse the function performed by thestretching device 10 y (mechanically operated). Even simpler is toswitch the direction of the motor electronically.

FIG. 88 shows an embodiment of the invention identical to that of FIG.86 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 56 is powered by thebattery 70 when the accumulator 58, suitably a capacitor, activates theelectric switch 72 to switch to an on mode. When the electric switch 72is in its on mode the internal control unit 56 is permitted to controlthe battery 70 to supply, or not supply, energy for the operation of thestretching device 10 y.

FIG. 89 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the stretching device 10 yy, the internal controlunit 56, motor or pump unit 44, and the external energy transmissiondevice 34 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 56, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably in the form of a sensor 76, may beimplanted in the patient for sensing a physical parameter of thepatient, such as a contraction wave in the esophagus 203 informing thepatient is eating. The internal control unit 56, or alternatively theexternal wireless remote control of the external energy transmissiondevice 34, may control the stretching device 10 y in response to signalsfrom the sensor 76. A transceiver may be combined with the sensor 76 forsending information on the sensed physical parameter to the externalwireless remote control. The wireless remote control may comprise asignal transmitter or transceiver and the internal control unit 56 maycomprise a signal receiver or transceiver. Alternatively, the wirelessremote control may comprise a signal receiver or transceiver and theinternal control unit 56 may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the stretching device 10y from inside the patient's body to the outside thereof.

Alternatively, the sensor 76 may be arranged to sense a functionalparameter of the stretching device 10 y.

Where the motor/pump unit 44 and battery 70 for powering the motor/pumpunit 44 are implanted, the battery 70 may be equipped with a transceiverfor sending information on the condition of the battery 70. To be moreprecise, when charging a battery or accumulator with energy feedbackinformation related to said charging process is sent and the energysupply is changed accordingly.

FIG. 90 shows an alternative embodiment wherein the stretching device 10y is regulated from outside the patient's body. The obesity treatmentsystem 28 comprises a stretching device 10 y connected to a battery 70via a subcutaneous switch 80. Thus, the regulation of the stretchingdevice 10 y is performed non-invasively by manually pressing thesubcutaneous switch, whereby the operation of the stretching device 10 yis switched on and off. It will be appreciated that the shown embodimentis a simplification and that additional components, such as an internalcontrol unit or any other part disclosed in the present application canbe added to the obesity treatment system.

FIG. 91 shows an alternative embodiment, wherein the obesity treatmentsystem 28 comprises a stretching device 10 y in fluid connection with ahydraulic fluid reservoir 52. Non-invasive regulation is performed bymanually pressing the hydraulic reservoir connected to the stretchingdevice 10 y.

A further embodiment of a system according to the invention comprises afeedback device for sending information from inside the patient's bodyto the outside thereof to give feedback information related to at leastone functional parameter of the stretching device or system or aphysical parameter of the patient, thereby optimizing the performance ofthe system.

One preferred functional parameter of the device is correlated to thetransfer of energy for charging the internal energy source.

In FIG. 92, an arrangement is schematically illustrated for supplying anaccurate amount of energy to a obesity treatment system 28 implanted ina patient, whose skin 36 is indicated by a vertical line. A stretchingdevice 10 y is connected to an implanted energy transforming device 30,likewise located inside the patient, preferably just beneath thepatient's skin 36. Generally speaking, the implanted energy transformingdevice 30 may be placed in the abdomen, thorax, muscle fascia (e.g. inthe abdominal wall), subcutaneously, or at any other suitable location.The implanted energy transforming device 30 is adapted to receivewireless energy E transmitted from an external energy source 34 aprovided in the external energy transmission device 34 located outsidethe patient's skin 36 in the vicinity of the implanted energytransforming device 30.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 34 a and an adjacent secondary coil arranged inthe implanted energy transforming device 30. When an electric current isfed through the primary coil, energy in the form of a voltage is inducedin the secondary coil which can be used to operate a stretching device.e.g. after storing the incoming energy in an energy storing device oraccumulator, such as a battery or a capacitor. However, the presentinvention is generally not limited to any particular energy transfertechnique, TET devices or energy storing devices, and any kind ofwireless energy may be used.

The amount of energy received inside the body to the device may becompared with the energy used by the device. The term used by the deviceis then understood to include also energy stored by the device. Theamount of transferred energy can be regulated by means of an externalcontrol unit 34 b controlling the external energy source 34 a based onthe determined energy balance, as described above. In order to transferthe correct amount of energy, the energy balance and the required amountof energy can be determined by means of an internal control unit 56connected to the stretching device 10 y. The internal control unit 56may thus be arranged to receive various measurements obtained bysuitable sensors or the like, not shown, measuring certaincharacteristics of the stretching device 10 y, somehow reflecting therequired amount of energy needed for proper operation of the stretchingdevice 10 y. Moreover, the current condition of the patient may also bedetected by means of suitable measuring devices or sensors, in order toprovide parameters reflecting the patient's condition. Hence, suchcharacteristics and/or parameters may be related to the current state ofthe stretching device 10 y, such as power consumption, operational modeand temperature, as well as the patient's condition reflected by, e.g.,body temperature, blood pressure, heartbeats and breathing.

Furthermore, an energy storing device or accumulator 58 may optionallybe connected to the implanted energy transforming device 30 foraccumulating received energy for later use by the stretching device 10y. Alternatively or additionally, characteristics of such anaccumulator, also reflecting the required amount of energy, may bemeasured as well. The accumulator may be replaced by a battery, and themeasured characteristics may be related to the current state of thebattery, such as voltage, temperature, etc. In order to providesufficient voltage and current to the stretching device 10 y, and alsoto avoid excessive heating, it is clearly understood that the batteryshould be charged optimally by receiving a correct amount of energy fromthe implanted energy transforming device 30. i.e. not too little or toomuch. The accumulator may also be a capacitor with correspondingcharacteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 56. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 56 is adapted to determine the energybalance and/or the currently required amount of energy, (either energyper time unit or accumulated energy) based on measurements made by theabove-mentioned sensors or measuring devices on the stretching device 10y, or the patient, or an energy storing device if used, or anycombination thereof. The internal control unit 56 is further connectedto an internal signal transmitter 82, arranged to transmit a controlsignal reflecting the determined required amount of energy, to anexternal signal receiver 34 c connected to the external control unit 34b. The amount of energy transmitted from the external energy source 34 amay then be regulated in response to the received control signal.

Alternatively, sensor measurements can be transmitted directly to theexternal control unit 34 b wherein the energy balance and/or thecurrently required amount of energy can be determined by the externalcontrol unit 34 b, thus integrating the above-described function of theinternal control unit 56 in the external control unit 34 b. In thatcase, the internal control unit 56 can be omitted and the sensormeasurements are supplied directly to the internal signal transmitter 82which sends the measurements over to the external signal receiver 34 cand the external control unit 34 b. The energy balance and the currentlyrequired amount of energy can then be determined by the external controlunit 34 b based on those sensor measurements.

Hence, the present solution employs the feedback of informationindicating the required energy, which is more efficient than previoussolutions because it is based on the actual use of energy that iscompared to the received energy. e.g. with respect to the amount ofenergy, the energy difference, or the energy receiving rate as comparedto the energy rate used by the stretching device. The stretching devicemay use the received energy either for consuming or for storing theenergy in an energy storage device or the like. The different parametersdiscussed above would thus be used if relevant and needed and then as atool for determining the actual energy balance. However, such parametersmay also be needed per se for any actions taken internally tospecifically operate the stretching device.

The internal signal transmitter 82 and the external signal receiver 34 cmay be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 82 and the externalsignal receiver 34 c may be integrated in the implanted energytransforming device 30 and the external energy source 34 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

To conclude, the energy supply arrangement illustrated in FIG. 28 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 56. A control signal reflectingthe required amount of energy is also created by the internal controlunit 56, and the control signal is transmitted from the internal signaltransmitter 82 to the external signal receiver 34 c. Alternatively, theenergy balance can be determined by the external control unit 34 binstead depending on the implementation, as mentioned above. In thatcase, the control signal may carry measurement results from varioussensors. The amount of energy emitted from the external energy source 34a can then be regulated by the external control unit 34 b, based on thedetermined energy balance. e.g. in response to the received controlsignal. This process may be repeated intermittently at certain intervalsduring ongoing energy transfer, or may be executed on a more or lesscontinuous basis during the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 34 a, suchas voltage, current, amplitude, wave frequency and pulsecharacteristics.

A method is thus provided for controlling transmission of wirelessenergy supplied to an electrically operable stretching device implantedin a patient. The wireless energy E is transmitted from an externalenergy source located outside the patient and is received by an internalenergy receiver located inside the patient, the internal energy receiverbeing connected to the stretching device for directly or indirectlysupplying received energy thereto. An energy balance is determinedbetween the energy received by the internal energy receiver and theenergy used for the stretching device. The transmission of wirelessenergy E from the external energy source is then controlled based on thedetermined energy balance.

A system is also provided for controlling transmission of wirelessenergy supplied to an electrically operable stretching device implantedin a patient. The system is adapted to transmit the wireless energy Efrom an external energy source located outside the patient which isreceived by an implanted energy transforming device located inside thepatient, the implanted energy transforming device being connected to thestretching device for directly or indirectly supplying received energythereto. The system is further adapted to determine an energy balancebetween the energy received by the implanted energy transforming deviceand the energy used for the stretching device, and control thetransmission of wireless energy E from the external energy source, basedon the determined energy balance.

The functional parameter of the device is correlated to the transfer ofenergy for charging the internal energy source.

In yet an alternative embodiment, the external source of energy iscontrolled from outside the patient's body to release electromagneticwireless energy, and released electromagnetic wireless energy is usedfor operating the stretching device.

In another embodiment, the external source of energy is controlling fromoutside the patient's body to release non-magnetic wireless energy, andreleased non-magnetic wireless energy is used for operating thestretching device.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 17-29 could be combined in many different ways. Forexample, the electric switch 38 operated polarized energy could beincorporated in any of the embodiments of FIGS. 11, 18-24, the hydraulicvalve shifting device 54 could be incorporated in the embodiment of FIG.16, and the gear box 74 could be incorporated in the embodiment of FIG.15. Please observe that the switch simply could mean any electroniccircuit or component.

Wireless transfer of energy for operating the stretching device has beendescribed to enable non-invasive operation. It will be appreciated thatthe stretching device can be operated with wire bound energy as well.One such example is shown in FIG. 93, wherein an external switch 84 isinterconnected between the external energy source 34 a and an operationdevice, such as an electric motor regulating the stretching device 10 y,by means of power lines 86 and 88. An external control unit 34 bcontrols the operation of the external switch to effect proper operationof the stretching device 10 y.

Hydraulic or Pneumatic Powering

FIGS. 94-97 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an apparatus for treatingobesity according to the invention.

FIG. 94 shows an apparatus for treating obesity as described above withreference to any of FIGS. 65-70. The apparatus comprises a stretchingdevice 10 y and further a separate regulation reservoir 16, a one waypump 44 and an alternate valve 54.

FIG. 95 shows the stretching device 10 y and a fluid reservoir 16. Bymoving the wall of the regulation reservoir or changing the size of thesame in any other different way, the adjustment of the stretching devicemay be performed without any valve, just free passage of fluid any timeby moving the reservoir wall.

96 shows the stretching device 10 y, a two way pump 44 and theregulation reservoir 16.

FIG. 97 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 16 and a servo reservoir 90. The servoreservoir 90 mechanically controls a stretching device 10 y via amechanical interconnection 94, the stretching device having anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 92 in fluid connection with the stretching device 10 y.Alternatively, the cavity contains compressible gas, which can becompressed and expanded under the control of the servo reservoir 90.

The servo reservoir 90 can also be part of the stretching device itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin 36 and is operated by pushing the outer surfacethereof by means of a finger. This obesity treatment system isillustrated in FIGS. 98a-c . In FIG. 98a , a flexible subcutaneousregulation reservoir 16 is shown connected to a bulge shaped servoreservoir 90 by means of a conduit 18. This bellow shaped servoreservoir 90 is comprised in a flexible stretching device 10 y. In thestate shown in FIG. 98a , the servo reservoir 90 contains a minimum offluid and most fluid is found in the regulation reservoir 16. Due to themechanical interconnection between the servo reservoir 90 and thestretching device 10 y, the outer shape of the stretching device 10 y iscontracted, i.e., it occupies less than its maximum volume. This maximumvolume is shown with dashed lines in the figure.

FIG. 98b shows a state wherein a user, such as the patient in with thestretching device is implanted, presses the regulation reservoir 16 sothat fluid contained therein is brought to flow through the conduit 18and into the servo reservoir 90, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the stretchingdevice 10 y so that it occupies its maximum volume, thereby stretchingthe stomach wall (not shown) which it contacts.

The regulation reservoir 16 is preferably provided with means forkeeping its shape after compression. This means, which is schematicallyshown as 16 a in the figure, will thus keep the stretching device 10 yin a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the obesity treatment system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 99 and 100 a-c. The block diagramshown in FIG. 99 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir16 and a servo reservoir 90. The servo reservoir 90 mechanicallycontrols a larger adjustable reservoir 92 via a mechanicalinterconnection 94. A stretching device 10 y having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 92 by supply of hydraulic fluid from the largeradjustable reservoir 92 in fluid connection with the stretching device10 y.

An example of this embodiment will now be described with reference toFIG. 100a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 16 is in fluid connection with a bellow shaped servo reservoir90 by means of a conduit 18. In the first closed system 16, 18, 90 shownin FIG. 34a , the servo reservoir 90 contains a minimum of fluid andmost fluid is found in the regulation reservoir 16.

The servo reservoir 90 is mechanically connected to a larger adjustablereservoir 92, in this example also having a bellow shape but with alarger diameter than the servo reservoir 90. The larger adjustablereservoir 92 is in fluid connection with the stretching device 10 y.This means that when a user pushes the regulation reservoir 16, therebydisplacing fluid from the regulation reservoir 16 to the servo reservoir90, the expansion of the servo reservoir 90 will displace a largervolume of fluid from the larger adjustable reservoir 92 to thestretching device 10 y. In other words, in this reversed servo, a smallvolume in the regulation reservoir is compressed with a higher force andthis creates a movement of a larger total area with less force per areaunit.

Like in the previous embodiment described above with reference to FIGS.98a-c , the regulation reservoir 16 is preferably provided with meansfor keeping its shape after compression. This means, which isschematically shown as 16 a in the figure, will thus keep the stretchingdevice 10 y in a stretched position also when the user releases theregulation reservoir. In this way, the regulation reservoir essentiallyoperates as an on/off switch for the obesity treatment system.

Method for the Surgical Treatment of a Patient Suffering from Reflux andObesity

A method for surgically treating an obese patient that also suffers fromreflux, the method comprising the steps of cutting an opening in theabdominal wall of the patient, dissecting an area around the stomach,placing an apparatus for treating to a part of the stomach wall of thepatient, and suturing the stomach wall. The apparatus for treatingobesity and reflux is preferably placed in a patient via a laparoscopicabdominal approach, comprising the steps of: inserting a needle or atube like instrument into the abdomen of the patient's body, using theneedle or a tube like instrument to fill the patient's abdomen with gasthereby expanding the patient's abdominal cavity, placing at least twolaparoscopic trocars in the patient's body, inserting a camera throughone of the laparoscopic trocars into the patient's abdomen, inserting atleast one dissecting tool through one of said at least two laparoscopictrocars and dissecting an intended placement area of the patient, andplacing an apparatus for treating obesity in connection with the stomachwall.

The methods could further comprise the step of postoperativelyregulating the at least one stretching device to: stretch a part of thestomach wall and regulate the stretching device from outside thepatient's body to affect the appetite of the patient.

Instruments

An intraluminar method of invaginating a stretching device 10 on theoutside of the stomach wall 12 will now be described with reference toFIGS. 101a-i . Initially, an instrument 600, preferably a gastroscopicinstrument, is inserted into the mouth of the patient, see FIG. 101a .The instrument comprises an injection device 601, 602 for injectingeither fluid or a device into the stomach of the patient. The instrument600 further comprises a control unit 606 adapted for controlling theoperation of the instrument. To this end, the control unit 606 comprisesone or more steering devices, in the embodiment shown in the figure inthe form of two joysticks 603 and two control buttons 604. A display 605is provided for displaying the image provided by an optical device forviewing inside the stomach, such as a camera (not shown) arranged at theouter end of the elongated member 607, see FIGS. 101e-i . The camera,which may comprise connecting electrical wires extending along theelongated member, may be assisted by a light source (not shown) placeddistally on the elongated member for illuminating the inside of thestomach. The optical device may also comprise optical fibers placedalong the elongated member and leading out from the patient's body forexternal viewing of the inside of the stomach.

The instrument is further inserted into the esophagus and into thestomach of the patient, see FIG. 101b . By means of the instrument 600,a hole 12 by is created in the wall of the stomach 12 y. To this end,the instrument is provided with one or more cutters 615 at the distalend thereof. These cutters can of course be designed in different ways,such as a toothed drum cutter rotating about the center axis of thetube-like instrument.

After cutting a hole in the stomach wall, the distal end of theinstrument 600 is inserted into and through the hole 2 by so that itends up outside the stomach wall 12 ay. This is shown in FIG. 101c ,showing a side view of the stomach 12 y, and FIG. 101d , which is asectional view through the stomach of FIG. 101c taken along the linesVd-Vd.

The instrument 600 is adapted to create a “cavity” or “pouch” on theoutside of the stomach around the hole 12 by in the stomach wall 12 y.Such an instrument and the method of providing the pouch will now bedescribed.

FIGS. 101e-i show a gastroscopic or laparoscopic instrument forinvaginating a stretching device 10 in the stomach wall 12 of thepatient by creating a pouch of stomach wall 12 material in which thestretching device 10 is placed. The instrument, generally designated600, comprises an elongated member 607 having a proximal end and adistal end, the elongated member 607 having a diameter less than that ofthe patient's esophagus and being flexible such as to allow introductionof the flexible elongated member 607 with its distal end first throughthe patient's throat, esophagus and into the stomach 12 to the stomachwall 12 a.

The stomach penetration device or cutter 615 is provided on theelongated member 607 at the distal en thereof for penetrating thestomach wall 12 a so as to create a hole in the stomach wall 12 a, toallow introduction of the elongated member 607 through the hole. Thestomach penetration device 615 could be adapted to be operable forretracting said stomach penetration device 615 after the stomach funduswall 12 a has been penetrated, for not further damaging tissue withinthe body. The instrument further comprises a special holding device 609provided on the elongated member 607 on the proximal side to thepenetration device 615.

The elongated member further comprises an expandable member 611 which isadapted to be expanded after the elongated member has penetrated thestomach wall 12 a and thereby assist in the creation of a cavity orpouch adapted to hold the volume filling device 610. The expandablemember 611 may comprise an inflatable circular balloon providedcircumferentially around the distal end portion of the flexibleelongated member 607.

The method steps when invaginating the volume filling device will now bedescribed in detail. After the instrument 600 has been inserted into thestomach 12, the stomach penetration device 615 is placed into contactwith the stomach wall 12, see FIG. 101e . The stomach penetration deviceor cutter 615 is then brought to create the hole 12 b in the stomachwall, whereafter at least the expandable member 611 is brought throughthe hole 12 b in the stomach wall. The special holding device 609 is inthis step brought to a holding state wherein it expands radially so asto form an essentially circular abutment surface to the stomach wall 12,see FIG. 101f . In this way, the insertion of the stomach penetrationdevice 615 and the expandable member 611 through the hole 12 in thestomach wall is limited to the position shown in FIG. 101 f.

The expandable member 611 is then expanded. In the case the expandablemember comprises a balloon or the like, air or other fluid is injectedinto it.

The part of the elongated member 607 comprising the expandable member611 is then retracted in the proximal direction, as indicated by thearrow in FIG. 101g , thereby pulling the stomach wall 612 into a basketor cup like structure created by the special holding device 609.

A suturing or stapling device 608 is further provided, either as adevice connected to the elongated member 607 or as a separateinstrument. The suturing or stapling member comprises a suturing orstapling end 613 which is adapted to close the cavity or pouch by meansof stomach to stomach sutures or staples 14.

In a further step, illustrated in FIG. 101h , an inflatable stretchingdevice 10 is placed in its deflated state in the cup like structure. Thestretching device 10 is then inflated to its inflated or expanded state,see FIG. 101i . This inflation of the stretching device 10 can beaccomplished by injecting a fluid or a gel into the deflated stretchingdevice. It can also be accomplished by injecting a material which isallowed to cure, thereby forming a solid device 10. Thus, the stretchingdevice 10 shown in FIGS. 101h and 101i can illustrate either aballoon-like device which is subsequently filled with fluid or gel oralternatively a material which is simply injected into the cup likestructure formed by the stomach wall 12.

The fluid which is used to fill the stretching device 10 could be anysuitable fluid suitable to fill the stretching device 10, such as a saltsolution. In another embodiment, when this fluid is a fluid which isadapted to be transformed into solid state, the fluid could be liquidpolyurethane.

In order to minimize or entirely eliminate leakage, the fluid isiso-tonic. i.e., it has the same osmolarity as human body fluids.Another way of preventing diffusion is to provide a fluid whichcomprises large molecules, such as iodine molecules.

The stomach-to-stomach sutures or staples 14 are preferably providedwith fixation portions exhibiting a structure, such as a net likestructure, adapted to be in contact with the stomach wall 12 to promotegrowth in of human tissue to secure the long term placement of thestretching device attached to the stomach wall.

Thereby is the inflatable stretching device 10 in its inflated orexpanded state invaginated by a stomach wall portion of the patient onthe outside of the stomach wall 12.

During one or more of the above described steps, the stomach may beinflated with gas, preferably by means of the gastroscopic instrument.

The stretching device 10 described above with reference to FIGS. 101a-ihas been described as an inflatable stretching device. It will beappreciated that it also can be an elastic stretching device with anelasticity allowing compression so as to be inserted into a gastroscopicinstrument and which expands to an expanded state after leaving theinstrument.

In one embodiment, the stretching device 10 comprises an inflatablestretching device 10 expandable to an expanded state. In this case, theinflatable stretching device 10 is provided with an inlet port 18 b fora fluid and is adapted to be connected to a gastroscopic instrument.This embodiment will now be described in detail with reference to FIGS.102a -102 d.

An inflatable stretching device in its non-expanded state is shown inFIG. 102a . It is essentially a balloon-like, deflated stretching device10 having an inlet port 18 b. In this state, the inflatable stretchingdevice 10 has a diameter of a few millimeters at the most, allowing itto be inserted into the stomach through the esophagus of the patient bymeans of a gastroscopic, tube-like instrument 600, or through alaparoscopic trocar in an abdominal laparoscopic method using a tubelike instrument 600 depicted in FIG. 102b . The instrument comprises anouter sleeve 600 a and an inner sleeve 600 b which can be displacedlongitudinally relatively to the outer sleeve. The inner sleeve isprovided with a cutter in the form of a cutting edge 615 at the distalend thereof. This cutting edge can be used for cutting a hole in thestomach wall, as will be explained in detail in the following.

When the instrument reaches a stomach wall, from the inside or outsidethereof, see FIG. 102c , the inner sleeve is brought forward from itsposition in the outer sleeve and into contact with the stomach wall 12a. The cutting edge 615 of the inner sleeve then cuts a hole in thestomach wall so as to allow subsequent insertion of the volume fillingdevice 10 into and through this hole, see FIG. 102d . In order to pushthe stretching device through the hole, a piston 602 may be provided inthe instrument. Thus, the instrument further comprises a piston 602adapted for pushing a deflated stretching device 10 out from a positionin the inner sleeve, this position being shown in FIG. 102b , to aposition outside of the inner sleeve, this being shown in FIG. 102 d.

In order to protect the deflated stretching device 10 from the cuttingedge 615 of the inner sleeve, a further protective sleeve (not shown)can be provided around the stretching device.

FIG. 102a-j shows an instrument for use in a method of engaging astretching device 10 to the stomach wall 12 of a patient. The instrumentis adapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 650 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 650 is adapted to be flexible bymeans of said elongated member 650 being made of a flexible oradjustable material. The elongated member 650 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 650 has a specialholding device 651 adapted to hold the stomach by means of mechanicalgrabbing members or vacuum. The special holding device 651 comprises afirst joint 652 and a second joint 653, which enables the specialholding device 651 be operable in relation to the elongated member 650and thereby place the part of the holding device 651 comprising themechanical grabbing members or vacuum elements in contact with thestomach wall 12 of the patient. FIG. 102b shows the special holdingdevice 651 when placed in contact with the stomach wall 12 of the humanpatient, after which the special holding member 651 connects to thestomach wall 12, for holding the stomach wall 12. FIG. 102c shows theinstrument when the step of advancing a pushing rod 654 from theelongated member 650 is performed. The pushing rod 654 pushes thestomach wall 12 to create a cavity or pouch thereof. FIG. 102d shows theinstrument turned 90° in relation to FIGS. 102a-c . This view shows thespecial holding members 651 a,b operably attached to two sides of theelongated member 650 and being in contact with the stomach wall 12,holding the stomach wall 12 as the pushing rod 654 pushes to create acavity or pouch. When the pushing rod 654 has pushed the stomach wall 12to a desired position the special holding devices 651 a,b moves towardsthe pushing rod 654 and thereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.103f shows the advancement of a suturing or stapling device 655 from theelongated member 650. The suturing or stapling device 655 is positionedin connection with the stomach wall after which the suturing or staplingdevice commences with the suturing or stapling of the stomach wall 12,creating a seal of stomach to stomach sutures or staplers 14. Theinstrument is moved along the stomach wall 12 of the patient and therebya cavity or pouch is created and sealed using the instrument, as shownin FIGS. 103g and 103h . When a cavity or pouch or desired size has beencreated and sealed an inserting member 656 is advanced from theelongated member 650. The inserting member 656 is adapted to insert astretching device 10 being inflatable, as described earlier in thisapplication. After the inserting member 656 has been positioned in thecavity or pouch the stretching device 10 is inserted through theinserting member 656 and into the cavity or pouch by means of apressurized fluid or gas, or a mechanical advancement member pushingsaid inflatable stretching device 10 into the cavity or pouch. Theinsertion member then inflates the inflatable stretching device with afluid or gas and seals of the final section of the pouch using stomachto stomach sutures or staplers 14. The embodiment described explains theprocess of inserting an inflatable stretching device, however it isequally conceivable that the stretching device 10 is expandable by meansof the stretching device 10 being made of an elastic material.

FIG. 104a-f shows an instrument for use in a method of engaging astretching device 10 to the stomach wall 12 of a patient. The instrumentis adapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 660 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 660 is adapted to be flexible bymeans of said elongated member 660 being made of a flexible oradjustable material. The elongated member 660 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 660 has multiple specialholding devices 661 adapted to hold the stomach by means of mechanicalgrabbing members or vacuum. The special holding devices 661 are lockedin a position alongside the elongated member 660 by means of a lockingring 662. The special holding devices are made of a flexible materialend pre-bent to expand into a funnel-shaped device when said lockingring 662 is removed. The special holding device in its funnel shapedexpandable state is shown in FIG. 104b . FIG. 104b further shows thespecial holding device 661 when placed in contact with the stomach wall12 of the human patient, after which the special holding member 661connects to the stomach wall 12, for holding the stomach wall 12. FIG.104c shows the instrument when the step of advancing a pushing rod 664from the elongated member 660 is performed. The pushing rod 664 pushesthe stomach wall 12 to create a cavity or pouch thereof. When thepushing rod 664 has pushed the stomach wall 12 to a desired position thespecial holding devices 661 moves towards the pushing rod 664 andthereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.104d shows the advancement of a suturing or stapling device 665 from theelongated member 660. The suturing or stapling device 665 is positionedin connection with the stomach wall 12 after which the suturing orstapling device 665 commences with the suturing or stapling of thestomach wall 12, creating a seal of stomach to stomach sutures orstaplers 14. Thereafter an inserting member 666 is advanced from theelongated member 660 and the special holding devices 661 are retracted.The inserting member 666 is adapted to insert a stretching device 10being inflatable, as described earlier in this application. After theinserting member 666 has been positioned in the cavity or pouch thestretching device 10 is inserted through the inserting member 666 andinto the cavity or pouch by means of a pressurized fluid or gas, or amechanical advancement member pushing said inflatable stretching device10 into the cavity or pouch. The insertion member 656 then inflates theinflatable stretching device with a fluid or gas and seals of the finalsection of the pouch using stomach to stomach sutures or staplers 14.The embodiment described explains the process of inserting an inflatablestretching device 10, however it is equally conceivable that thestretching device 10 is expandable by means of the stretching device 10being made of an elastic material. FIG. 40 f shows the stretching device10 as the stretching device 10 is invaginated in the stomach wall 12, ina cavity or pouch sealed with stomach to stomach sutures or staplers 14.

FIG. 105a shows an instrument used in a method of engaging thestretching device according to any of the embodiments of the applicationto the stomach wall 12. The instrument comprises an elongated member 670which is adapted to be flexible by means of a construction comprisingmultiple ring shaped members, however it is equally conceivable thatsaid elongated member 670 is adapted to be flexible by means of saidelongated member 670 being made of a flexible or adjustable material.The elongated member 670 is inserted into the body and placed inproximity to the stomach wall 12 of the patient, from the insidethereof. A stomach penetrating member 672 is placed in the distal end ofthe elongated member 670, retractably fixated to a protective sleeve 673adapted to protect the tissue of the body from the sharp penetratingmember 672 or cutter 672 after the cutting operation has been performed.

FIG. 105b shows the instrument comprising the elongated member 670 afterthe cutting operation has been performed and the stomach penetratingmember or cutter 672 has been retracted into the protective sleeve 673.A guiding wire 671 is pushed through the elongated member 670, throughthe hole made in the stomach wall 12 and out through the abdomen andplaced on the inside of the patients skin, which is penetrated from theoutside to enable the guiding wire 671 to exit the abdomen. The guidingwire 671 can then be used to guide a conduit 18 or a lead attached tothe stretching device 10 being placed in the stomach from the insidethereof. The stretching device 10 with the conduit 18 or electrical leadbeing a stretching device 10 according to any of the embodiments of thisapplication. The guiding of the conduit 18 or electrical lead enablesthe attachment of the conduit 18 or electrical lead to a control unit 42placed subcutaneously in the patient from the outside of the abdomen.

FIG. 106 shows a flowchart describing the steps needed in aninterluminar method of inserting an apparatus for stretching a portionof the stomach wall, the method comprises the steps of inserting aninstrument into the esophagus 203 of the patient, step 1 a, inserting anapparatus into the stomach of the patient through the esophagus 203using the instrument, step 2 a, placing the apparatus 10 in contact withthe stomach wall 12, step 3 a, fixating the apparatus to the stomachwall 12 such that the apparatus can stretch a part of the stomach wall12. The method described could further comprise the step ofnon-invasively regulating the device after the placing of the apparatushas been completed.

FIG. 107 shows a flowchart describing the steps needed in an abdominalmethod of inserting an apparatus for stretching a portion of the stomachwall, the method comprises the steps of cutting a hole in the abdominalwall of said patient, step 1 b, dissecting an area around the stomach,step 2 b, placing said apparatus in contact with the stomach, step 3 band fixating direct or indirect through invagination of the stomach wallthe apparatus to the stomach wall such that the apparatus can stretch aportion of said stomach wall step 4 b. The method described couldfurther comprise the steps of closing the hole in the abdomen usingsutures or staplers 14 and non-invasively regulating the device afterthe placing of the apparatus has been completed.

1-281. (canceled)
 282. An apparatus for treating reflux disease of ahuman or animal mammal patient, comprising: an implantable stimulationdevice adapted to engage with the cardia sphincter of the patient; and acontrol device for controlling the stimulation device to stimulate thecardia sphincter by providing electrical energy pulses for increasing asphincter tonus so that the cardia closes; wherein: the control deviceis adapted to, in an operational state, cause the stimulation device tostimulate the cardia sphincter with at least two pulse trains; at leastsome of the pulses within at least one of the pulse trains are separatedfrom each other by a first time break; the at least two pulse trains areseparated from each other by a second time break; and the second timebreak is longer than the first time break.
 283. The apparatus accordingto claim 1, wherein: the control device is adapted to, in theoperational state, cause the stimulation device to stimulate the cardiasphincter with at least two pulse train segments; each pulse trainsegment comprises at least two pulse trains that are separated from eachother by the second time break; the at least two pulse train segmentsare separated from each other by a third time break; and the third timebreak is longer than the second time break.
 284. The apparatus accordingto claim 1 or 2, further comprising an implantable movement restrictiondevice adapted to be implanted in connection with the fundus wall of thepatient's stomach fundus wall, in a non-encircling manner with respectto the patient's stomach.
 285. The apparatus according to claim 3,wherein the movement restriction device adapted to be arranged such thata substantial pan of the outer surface of the movement restrictiondevice rests against the stomach wall in a position between thepatient's diaphragm and at least a portion of the lower part of theinvaginated stomach fundus wall, such that movement of the cardiac notchof the patient's stomach towards the patient's diaphragm is restrictedwhen the movement restriction device is invaginated, to thereby preventthe cardia from sliding through the patient's diaphragm opening into thepatient's thorax, so as to maintain a supporting pressure against thepatient's cardia sphincter muscle exerted from the patient's abdomen.286. The apparatus according to claim 4, wherein the movementrestriction device has a size of at least 125 mm3.
 287. The apparatusaccording to claim 4 or 5, wherein the movement restriction device has acircumference of at least 15 mm.
 288. The apparatus according to any oneof claims 4 to 6, wherein the outer surface of the movement restrictiondevice comprises a biocompatible material.
 289. The apparatus accordingto any one of claims 4 to 7, further comprising an implantable fixationdevice that is adapted to, when implanted in the patient, attach themovement restriction device to the fundus wall to keep the movementrestriction device in said position.
 290. The apparatus according to anyone of the preceding claims, wherein the control device is adapted toset the stimulation device in a state wherein it is out of operationsuch that the cardia sphincter is not stimulated when the patientswallows.
 291. The apparatus according to any one of the precedingclaims, wherein the control device is operable by the patient such thatthe patient is allowed to set the stimulation device in the operationalstate and in the state wherein it is out of operation.
 292. Theapparatus according to any one of the preceding claims, wherein thecontrol device is adapted to be implanted in the body of the patient.293. The apparatus according to claim 4, wherein the stimulation deviceis adapted to be arranged within the movement restriction device, andfurther comprises an electrode adapted to engage with the cardiasphincter so as transmit the electrical energy pulses to the cardiasphincter.
 294. The apparatus according to any one of claims 1 to 11,wherein the stimulation device is adapted to be placed on the outside ofthe patient's stomach.
 295. The apparatus according to any one of thepreceding claims, further comprising a wireless remote control fornon-invasively controlling the apparatus.
 296. The apparatus accordingto any one of the preceding claims, further comprising a wireless energytransmitter non-invasively energizing the apparatus.